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Regulatory Affairs 2018

Session/Tracks

Track 1: Regulatory Affairs

Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals , veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities.

Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorized medicinal products. The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical industry. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

Regulatory Affairs Professional Society-RAPS; Canadian Association of Professionals in Regulatory AffairsInternational Generic and Biosimilar Medicines AssociationThe Organization for Professionals in Regulatory Affairs- TOPRADrug Information AssociationBelgian Regulatory Affairs SocietyRocky Mountain Regulatory Affairs SocietyInternational Research –Based Pharmaceutical Manufacturers Association

Track 2: Regulatory Affairs in Pharmacovigilance

Regulatory Affairs (RA), likewise called government issues, are a calling inside managed enterprises, for example, pharmaceuticals, medicinal gadgets, vitality, saving money, telecom and so on. Administrative Affairs likewise has a certain importance inside the human services enterprises (pharmaceuticals, therapeutic gadgets, biologics and useful nourishments). Administrative issues (therapeutic issues) experts (otherwise known as administrative experts) typically have duty regarding the accompanying general territories:

Working with government, state and neighborhood administrative offices and faculty on particular issues influencing their business i.e., working with so much office as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and restorative gadgets); The Department of Energy; or the Securities and Exchange Commission (banking). Advising their organizations on the administrative angles and atmosphere that would influence proposed exercises. i.e., portraying the "administrative atmosphere" around issues, for example, the advancement of professionally prescribed medications and Sarbanes-Oxley consistence.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

European Generic and Biosimilar Medicines AssociationAssociation of International Pharmaceutical ManufacturersInternational Pharmaceutical Federation-FIP; Society of BiomaterialsAmerican Association of Pharmaceutical Scientists-AAPSInternational Society of Drug Delivery Sciences and Technology-APGIJapan Society of Drug Delivery SystemEuropean Federation of Biotechnology.

Track 3: Clinical Affairs & Regulatory Strategies

An administrative science driven administrative procedure is crucial as a component of today's biopharmaceutical item early advancement arranging. An all-around arranged administrative methodology will adjust the proposed clinical advancement arrangement with business targets, and pre-emptively distinguish challenges, and also, proposed elective/creative ways to deal with new item improvement which influence new measures for confirmation era supporting proceeding with improvement and worldwide business sector approval. An administrative methodology characterizes key issues/difficulties to proactively talk about with Regulatory powers furthermore characterizes key system points of reference that are frequently considered business impetuses driving speculator intrigue and financing. In particular, an auspicious, very much arranged and all around kept up administrative technique, with proactive and collective cooperation with administrative powers, is regularly a separating element for industry pioneers putting up monetarily fruitful and creative items for sale to the public in today's aggressive commercial center. Administrative procedure is a noteworthy segment of fruitful biopharmaceutical item improvement. Covance Global Regulatory Affairs gets ready and keeps up administrative science driven and item particular worldwide administrative systems for some item sorts, e.g., drugs, biologics, drug-gadget mixes, antibodies, quality treatments, cell-treatments, over a scope of restorative territories and full administrative technique support for item improvement activities.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

Regulatory Affairs Professional Society-RAPS; Canadian Association of Professionals in Regulatory AffairsInternational Generic and Biosimilar Medicines AssociationThe Organization for Professionals in Regulatory Affairs- TOPRADrug Information AssociationBelgian Regulatory Affairs SocietyRocky Mountain Regulatory Affairs SocietyInternational Research –Based Pharmaceutical Manufacturers Association

Track 4: Regulatory Strategies and Developments

A regulatory strategy is a formal document that aligns the regulatory activities to bring a new or modified product to market with the business strategy for that product. It provides overall definition and direction to the project team for the product being developed by identifying the important regulatory elements to be addressed to market the device. Within a company, there are usually many players from a variety of departments who work on developing the regulatory strategy. Since this strategy involves all aspects of a drug, individuals with expertise in chemical synthesis, toxicology, biology, clinical and regulatory affairs, marketing, government affairs, and reimbursement should all provide input into the regulatory strategy to ensure it is as comprehensive as possible.

The regulatory strategy document has three main purposes. It needs to be:

  • A tracking tool to summarize key agreements reached with health authorities
  • A planning tool that documents timelines and lists topics to address in future meetings with health authorities
  • A risk register to record key issues that could impact timelines, costs or commercial value for the project

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

European Generic And Biosimilar Medicines AssociationAssociation of International Pharmaceutical ManufacturersInternational Pharmaceutical Federation-FIP; Society of BiomaterialsAmerican Association of Pharmaceutical Scientists-AAPSInternational Society of Drug Delivery Sciences and Technology-APGIJapan Society of Drug Delivery SystemEuropean Federation of Biotechnology.

Track 5: Penalties for Regulatory Non-compliance

Non-compliance costs are costs which result from a failure to comply with regulation. These costs are not considered to be part of the regulatory burden for the purposes of the RBM. This includes penalties and associated activities that are required to be undertaken as a result of non-compliance with a regulation. Regulatory impacts that arise, up to the point that action is taken to respond to the suspicion of a specific instance of non-compliance, are included in the RBM framework. This includes risk based frameworks that may target certain populations without a specific instance of suspicion. “FCPIAA defines a CMP as any penalty, fine, or other sanction that is for a specific monetary amount as provided by Federal law; or has a maximum amount provided for by Federal law; and is assessed or enforced by an agency pursuant to Federal law; and is assessed or enforced pursuant to an administrative proceeding or a civil action in the Federal Courts”. Failure to comply with the law can lead to enforcement action including one or more of the following: on-the-spot fines, prosecution, which carries a maximum fine of $12,110, disciplinary action, ranging from fines to cancellation of the license.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

Regulatory Affairs Professional Society-RAPS; Canadian Association of Professionals in Regulatory AffairsInternational Generic and Biosimilar Medicines AssociationThe Organization for Professionals in Regulatory Affairs- TOPRADrug Information AssociationBelgian Regulatory Affairs SocietyRocky Mountain Regulatory Affairs SocietyInternational Research –Based Pharmaceutical Manufacturers Association

Track 6: Biologics & Biosimilars

biopharmaceutical, otherwise called a biologic therapeutic item or biologic, is any restorative item made in, extricated from, or semi orchestrated from organic sources. Not quite the same as synthetically incorporated pharmaceuticals, they incorporate immunizations, blood, or blood segments, allergenic, substantial cells, quality treatments, tissues, recombinant restorative protein, and living cells utilized as a part of cell treatment. Biologics can be made out of sugars, proteins, or nucleic acids or complex mixes of these substances, or might live cells or tissues. They are confined from normal sources—human, creature, or microorganism. Phrasing encompassing biopharmaceuticals fluctuates amongst gatherings and elements, with various terms alluding to various subsets of therapeutics inside the general biopharmaceutical class. Some administrative offices utilize the terms natural restorative items or remedial organic item to allude particularly to designed macromolecular items like protein-and nucleic acid–based drugs, recognizing them from items like blood, blood segments, or antibodies, which are typically extricated specifically from a natural source Gene-based and cell biologics, for instance, frequently are at the front line of biomedical research, and might be utilized to treat an assortment of therapeutic conditions for which no different medications are accessible.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

Regulatory Affairs Professional Society-RAPS; Canadian Association of Professionals in Regulatory AffairsInternational Generic and Biosimilar Medicines AssociationThe Organization for Professionals in Regulatory Affairs- TOPRADrug Information AssociationBelgian Regulatory Affairs SocietyRocky Mountain Regulatory Affairs SocietyInternational Research –Based Pharmaceutical Manufacturers Association

Track 7: Global Regulatory Intelligence

Ever-proliferating and changing global regulations generate complex challenges of execution in global market clearance operations.

Mission-critical decisions are delayed, trapping new international revenue until market clearance process issues are resolved. Workflow is confounded as information conflicts from sales-focused distributors, newly-appointed foreign regulators, and legacy resources are reconciled- and as definitive answers are sought. Governance is compromised as information gaps reduce assurance levels and impair risk management of clearance-related penalties, fines, and legal costs.

And the high level of business performance required to create value from ongoing medtech industry consolidation is not achievable, since global market clearance operations are incapable of rapidly completing new market clearance submissions for newly-acquired product lines.

Unlike repackaged RI databases designed for the pharmaceutical industry, the clinivation Worldview Enterprise Solution for On-Demand Global Regulatory Intelligence accelerates the market clearance cycle.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

Regulatory Affairs Professional Society-RAPS; Canadian Association of Professionals in Regulatory AffairsInternational Generic and Biosimilar Medicines AssociationThe Organization for Professionals in Regulatory Affairs- TOPRADrug Information AssociationBelgian Regulatory Affairs SocietyRocky Mountain Regulatory Affairs SocietyInternational Research –Based Pharmaceutical Manufacturers Association

Track 8: Impact of Brexit on Regulatory Framework

The most important piece of UK legislation that would need to be repealed is the European Communities Act 1972 (ECA), which provides for the supremacy of EU law. Repealing the ECA will bring an end to the constitutional relationship that exists between EU and UK law. Moreover, the vast amounts of secondary legislation that have been passed with the objective and justification of implementing EU law would have to be considered by the Government. EU Regulations rely on the principle of direct applicability, which means that unlike EU Directives, they are directly implemented into UK law without the need for legislation from the UK Parliament. In this light, Regulations are more powerful legislative tools for the EU because of their immediate applicability. The status of existing Regulations will be addressed in the Great Repeal Bill, although as noted above, in many cases amendments will likely be needed to take into account the UK’s new relationship with the EU. The Court of Justice of the European Union (CJEU) situated in Luxembourg is the final arbiter on questions of the interpretation of EU law. In her first speech setting out the UK Government’s priorities for Brexit on 17 January 2017, the Prime Minister restated her position that the UK is not prepared to continue to be subject to the jurisdiction of the CJEU.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

European Generic and Biosimilar Medicines AssociationAssociation of International Pharmaceutical ManufacturersInternational Pharmaceutical Federation-FIP; Society of BiomaterialsAmerican Association of Pharmaceutical Scientists-AAPSInternational Society of Drug Delivery Sciences and Technology-APGIJapan Society of Drug Delivery SystemEuropean Federation of Biotechnology.

 

Track 9: Regulatory Communications and Submissions

Due to the growing interest in marketing new products, it is pivotal to establish a superior level of medical writing and regulatory operations. Executives within these roles need to create and manage successful submissions, as well as streamline timelines, to accelerate approval.

Attending the Optimizing Regulatory Communications and Submissions conference will aid delegates in expediting the approval of drugs while meeting requirements for different regulatory agencies worldwide. In addition, attendees will overcome key operational challenges impacting the approval process to enhance the quality of submissions.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

Regulatory Affairs Professional Society-RAPS; Canadian Association of Professionals in Regulatory AffairsInternational Generic and Biosimilar Medicines AssociationThe Organization for Professionals in Regulatory Affairs- TOPRADrug Information AssociationBelgian Regulatory Affairs SocietyRocky Mountain Regulatory Affairs SocietyInternational Research –Based Pharmaceutical Manufacturers Association

Track 10: Marketing Authorizations-Affordable Healthcare and Fair Trade

This establishment level module is the perfect acquaintance for new participants with the field of pharmaceutical administrative issues and consistence. It portrays the central prerequisites that must be fulfilled to pick up and keep up endorsement to advertise restorative items in the USA and Europe. The lawful structure and the parts of significant players in control are displayed. The life-cycle of a medication is sketched out. The different systems accessible for appraisal and endorsement of items are depicted and their prerequisites laid out. Commitments to be satisfied in the wake of promoting endorsement are examined. Worldwide administrative undertakings bunches in industry give around the world, key initiative in and far reaching course of the legislature administrative necessities for item presentation and commercialization, using administrative learning to guarantee consistence and administrative knowledge and make open doors in an exceedingly controlled environment. The worldwide administrative undertakings bunch has vital and operational capacities, requiring accuracy and faultless execution, as an organization's prosperity depends on, partially, the direction and thorough appraisal gave by the administrative issues group. The key item advancement, assembling and enlistment turning points, (for example, Investigational New Drug documenting, end of stage II, stage III, New Drug Application entries, administrative office audit timetable and item endorsements), which are the corporate valuation and choice focuses, depend on basic administrative interface goalposts and developments. This underscores the significance of key administrative commitment to the business. Keeping in mind the end goal to be profitable donors and basic business accomplices, the worldwide administrative undertakings association must create instruments and build up frameworks to guarantee it has the right individuals and ability, capable procedures, productive profitability, sensational execution and accuracy in arranging.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

European Generic and Biosimilar Medicines AssociationAssociation of International Pharmaceutical ManufacturersInternational Pharmaceutical Federation-FIP; Society of BiomaterialsAmerican Association of Pharmaceutical Scientists-AAPSInternational Society of Drug Delivery Sciences and Technology-APGIJapan Society of Drug Delivery SystemEuropean Federation of Biotechnology.

Track 11: Regulatory Requirements for Pharmaceuticals

The new medication endorsement process have been made into three stages for improvement in comprehension - the principal stage is pre-advertising implied for revelation, advancement and clinical concentrates, second stage for promoting approval of medication and third is for post showcasing. Firstly, preclinical investigations of a medication are finished to guarantee adequacy and security, and after that application for behavior of clinical trials is submitted to the CDSCO. From that point, the clinical trials can be led (stage I to stage IV). These studies are performed to guarantee the viability, wellbeing and upgrading the measurements of medication in people. After the culmination of clinical investigations of the medication, then an application to the skilled power of India for the endorsement of medication for advertising is submitted. The able power audit the application and affirm the medication for advertising just if the medication is observed to be sheltered and successful in individual or the medication have more alluring impact as contrast with the danger.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

Regulatory Affairs Professional Society-RAPS; Canadian Association of Professionals in Regulatory AffairsInternational Generic and Biosimilar Medicines AssociationThe Organization for Professionals in Regulatory Affairs- TOPRADrug Information AssociationBelgian Regulatory Affairs SocietyRocky Mountain Regulatory Affairs SocietyInternational Research –Based Pharmaceutical Manufacturers Association

Track 12: Regulatory Challenges for Medical Devices

As therapeutic gadget quality certification and administrative undertakings experts, it can test to remain focused of changes occurrence in our industry. Administrative controls for restorative gadgets are rare in the creating scene, despite the fact that usage of national medicinal gadget directions will frequently address the very issues brought up in nations as significant attentiveness toward patient wellbeing. Case of these issues incorporate the unlawful re-preparing and re-bundling of utilized syringes for re-deal; the accessibility available of hardware that fizzles least quality and security benchmarks; or just no hint of what gadgets are being sold in the nation, nor by whom. Such a posting is crucial to empower governments to issue cautions or reviews for perilous or inadequate things.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

European Generic and Biosimilar Medicines AssociationAssociation of International Pharmaceutical ManufacturersInternational Pharmaceutical Federation-FIP; Society of BiomaterialsAmerican Association of Pharmaceutical Scientists-AAPSInternational Society of Drug Delivery Sciences and Technology-APGIJapan Society of Drug Delivery SystemEuropean Federation of Biotechnology.

Track 13: Medical Device & Combination Products Regulations

Blend items are remedial and indicative items that consolidate medications, gadgets, and/or organic items. FDA hopes to get expansive quantities of blend items for audit as innovative advances keep on merging item sorts and obscure the verifiable lines of partition between FDA's therapeutic item focuses, which are comprised of the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH). Since mix items include parts that would regularly be controlled under various sorts of administrative powers, and much of the time by various FDA Centers, they raise testing administrative, strategy, and audit administration challenges. Contrasts in administrative pathways for every part can affect the administrative procedures for all parts of item improvement and administration, including preclinical testing, clinical examination, showcasing applications, assembling and quality control, antagonistic occasion reporting, advancement and promoting, and post-endorsement alterations.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

Regulatory Affairs Professional Society-RAPS; Canadian Association of Professionals in Regulatory AffairsInternational Generic and Biosimilar Medicines AssociationThe Organization for Professionals in Regulatory Affairs- TOPRADrug Information AssociationBelgian Regulatory Affairs SocietyRocky Mountain Regulatory Affairs SocietyInternational Research –Based Pharmaceutical Manufacturers Association

Track 14: Best Industry Practices

Drug business is one in everything about nation's most critical monetary motors, trade $15 billion in stock yearly and a couple of its processing plants region unit preeminent. The government office has built up a progression of tips for creating GXP (which incorporates GCPGLP and GMP directions) that shield each the life sciences business furthermore the clients they serve. In order to help FDA-directed firms, expert control offers partner in incorporated quality and consistence administration code that guarantees GLP, GCP and GMP rules consistence. Industry practices is likewise some portion of value danger administration framework, Pharma Regulatory Affairs, Audits and assessments, acceptance strategies (process approval and expository approval), Qualification, acceptance, adjustment, upkeep, hazard investigation Drug Safety and Good Pharmacovigilance hones. Some of our product framework applications which will encourage with GLP GCP GMP rules epitomize the resulting arrangements: Document Control/Document Management, Corrective Action Preventive Action (CAPA), alteration administration, guiding Management, resistance Automation programming framework, Audit Management in venture with GLP GCP GMP rules, customer protests programming framework, shapes based strategy robotization, electronic entries.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

European Generic and Biosimilar Medicines AssociationAssociation of International Pharmaceutical ManufacturersInternational Pharmaceutical Federation-FIP; Society of BiomaterialsAmerican Association of Pharmaceutical Scientists-AAPSInternational Society of Drug Delivery Sciences and Technology-APGIJapan Society of Drug Delivery SystemEuropean Federation of Biotechnology.

Track 15: Intellectual Property Rights

In the EU, an organic thoughtful item is one amongst the dynamic substance(s) made from or separated from a natural (living) framework, and requirements, also to physico-compound testing, natural testing for full characterization. The characterization of a natural medicative item could be a blend of testing the dynamic substance and hence the last medicative item along the edge of the get together strategy and its administration. Central thoughts of Intellectual Property Management (IPM) and its significance is a goad to human force and in this manner is the headway of financial and social improvement. It furthermore gives defense on the occasion Associate in usage of an IPM technique together with the administration of material ownership (IP) in a web setting. Investigative control law more often than not gives the creator of partner in scholarly creation restrictive rights for abusing and taking advantage of their creation. Experimental order insurance is intended to fortify the force of the human personality for the upside of all by verifying that benefits got from misusing a creation advantage the maker. This may energize action and allow financial specialists in investigation and improvement a decent go ahead their speculation. Experimental order presents on individuals, undertakings or option elements the right to bar others from the vocation of their manifestations wellbeing and quality control in naming. Therefore, material ownership rights (IPRs) could have an on the spot Associate in generous effect on exchange on the grounds that the proprietor of an IPR could - through the social control of such a privilege - prevent the assembling, use or offer of an item which incorporates the IPR. Therefore administration over the immaterial (IPR) suggests administration of the stock and markets. Exploratory order security energizes the production, conveyance and discourse demonstration of the creation to the overall population, rather than keeping it mystery though at indistinguishable time urging mechanical endeavours to choose imaginative works for abuse. Material ownership lawful titles identifies with the securing and utilization of an assortment of rights covering totally distinctive type of manifestations. Licenses in the pharmaceutical business incorporate both lawful and moral issues.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

Regulatory Affairs Professional Society-RAPS; Canadian Association of Professionals in Regulatory AffairsInternational Generic and Biosimilar Medicines AssociationThe Organization for Professionals in Regulatory Affairs- TOPRADrug Information AssociationBelgian Regulatory Affairs SocietyRocky Mountain Regulatory Affairs SocietyInternational Research –Based Pharmaceutical Manufacturers Association

Track 16: Current GMP Guidelines (cGMP) & GxP in Pharmaceuticals

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.

The purpose of the GxP quality guidelines is to ensure a product is safe and meets its intended use. GxP guides quality manufacture in regulated industries including food, drugs, medical devices and cosmetics.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

Regulatory Affairs Professional Society-RAPS; Canadian Association of Professionals in Regulatory AffairsInternational Generic and Biosimilar Medicines AssociationThe Organization for Professionals in Regulatory Affairs- TOPRADrug Information AssociationBelgian Regulatory Affairs SocietyRocky Mountain Regulatory Affairs SocietyInternational Research –Based Pharmaceutical Manufacturers Association

Track 17: The Role of 'c' in cGMP

The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "C" in CGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's quality standards.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

European Generic and Biosimilar Medicines AssociationAssociation of International Pharmaceutical ManufacturersInternational Pharmaceutical Federation-FIP; Society of BiomaterialsAmerican Association of Pharmaceutical Scientists-AAPSInternational Society of Drug Delivery Sciences and Technology-APGIJapan Society of Drug Delivery SystemEuropean Federation of Biotechnology.

Track 18: Good Clinical Practices & Good Laboratory Practices

The role of ICH in designing GCP principles is to provide an ethical treatment to the subjects who are involved in the clinical trials. Conference on Good Clinical Practices is important because it is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The GLP Principles describe requirements for and provide general guidance on the conduct of all nonclinical health and environmental safety studies, including invitro studies. Pre-clinical trials assess the toxicity of a drug and examine its potential effects on the human body. These trials are conducted in-vitro which is required to proceed with clinical trials. Good laboratory practices should be followed for these pre-clinical trials.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

Regulatory Affairs Professional Society-RAPS; Canadian Association of Professionals in Regulatory AffairsInternational Generic and Biosimilar Medicines AssociationThe Organization for Professionals in Regulatory Affairs- TOPRADrug Information AssociationBelgian Regulatory Affairs SocietyRocky Mountain Regulatory Affairs SocietyInternational Research –Based Pharmaceutical Manufacturers Association

Track 19: Softwares in GMP and GCP

The use of GMP software systems in regulated industries is vital throughout all aspects of the manufacturing process. Quality management software provides a flexible and configurable platform for tracking and managing quality and regulatory compliance events to ensure that manufacturing activities are continually measured, monitored and improved upon.  In addition to managing all aspects of the audit process, GMP software solution manages the associated findings or observations, corrective and preventive actions (CAPAs), risk assessment, risk management and the analysis and approvals of changes. This software also manages deviations, process validation, complaint handling, manufacturing incidents, training records and more.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

European Generic and Biosimilar Medicines AssociationAssociation of International Pharmaceutical ManufacturersInternational Pharmaceutical Federation-FIP; Society of BiomaterialsAmerican Association of Pharmaceutical Scientists-AAPSInternational Society of Drug Delivery Sciences and Technology-APGIJapan Society of Drug Delivery SystemEuropean Federation of Biotechnology

Track 20: GMP in Food Industry

The Quality control in typical food processing has a significant role in assuming a high quality, safe and nutritious food supply for the public, for their good health and for the economic benefits derived from trade of safe and high quality food. Quality control conference also plays a major role in food industry. Hazard Analysis & Critical Control Points (HACCP) is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. Food, Drug, and Cosmetic Act is a set of laws giving authority to the US-FDA to oversee the food safety, safety of drugs, and cosmetics. Cleaning, disinfection and hygiene should be strictly maintained in food industry.

Related Conferences:

Advertising and Promotion Regulatory Affairs Conference Mar 08-09, 2018 North Bethesda, Maryland, USA; 20th International Conference on Pharmaceutical Regulatory Affairs August 13 - 14 2018, Venezia, Italy; Pharmaceutical Regulatory Affairs In Asia April 04-06, 2018 London, UK; Global Summit on Biopharma and Biotherapeutics May 14-15, 2018 Montreal, Canada; Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens March 22, 2018 Orlando, Florida, USA; 17th Regulatory and Scientific Affairs Conference     January 25-26 2018 London, Great Britain; 7th International conference on Pharmaceutical Auditing June 08-09, 2018 Baltimore, USA.

Related Societies:

Regulatory Affairs Professional Society-RAPS; Canadian Association of Professionals in Regulatory AffairsInternational Generic and Biosimilar Medicines AssociationThe Organization for Professionals in Regulatory Affairs- TOPRADrug Information AssociationBelgian Regulatory Affairs SocietyRocky Mountain Regulatory Affairs SocietyInternational Research –Based Pharmaceutical Manufacturers Association

 

About Conference


About Conference

Regulatory Affairs 2018 conference will facilitate networking with experts in area of Regulatory affairs. By attending the conference one can benefit from Optimizing Regulatory Communications and Submissions, development of on-going regulatory strategies by the regulatory authorities, current trends in pharmaceutical product development in manufacturing.

Good Reasons Not to Miss Regulatory Affairs 2018

1. You can listen to world-renowned speakers.

2. The program focuses both to scientific value and impact on the industrial world.

3. You can meet companies and stakeholders in the regulatory field.

2018 Key Themes

  • Product Registration & Submission
  • Global Guidelines for the Development of Biologics
  • Medical Device & Combination Products Regulations
  • Accelerating Approval of New Drugs
  • ASEAN Labelling Harmonisation
  • Regulatory & Clinical Affairs
  • Regulatory & Pharmacovigilance
  • Penalities for Regulatory Non-compliance
  • Regulatory Enforcement & Inspection

Top Reasons to Attend

  • Gain critical advise from industry experts on regulation matters
  • Meet and network 100+ industry leaders and peers, with co-located events under PharmaCon
  • Get detailed information of the new regulation and its foreseen challenges in Asia Pacific
  • Benchmark your regulatory strategies with the other leaders
  • Breadth and depth of key topics on production registration, submission, pharmacovigilance, clinical regulatory requirements will be addressed

Who Should Attend and Who You’ll Meet ?

Directors/Senior Directors/Executive Directors and Vice Presidents/ Senior Vice Presidents /patents/attorney/Executive Vice Presidents and Heads/Leaders/Partners of

  • Clinical Research Sites
  • Pharma/Biotech and Medical Device industries
  • Hospitals, Associations
  • Pharmacoepidemology
  • Quality Analysts, Consultants

Medical Directors, Principal Investigators, Methodologists, and other Regulatory professionals along with Academicians: University Faculties like Directors, Senior Professors/Assistant Professors/ Associate Professor, Research Scholars, scientists who are related to clinical and medical research.

  • Regulatory professionals with responsibilities in:
  • Regulatory Affairs
  • Pharmacovigilance
  • Quality Assurance
  • Clinical Research & Development 
  • Intellectual Property Rights
  • Clinical Trial Management/Clinical Trial Supplies.

 

Market Analysis

Global Market Analysis for Regulatory Affairs:

Regulatory Affairs Department is the backbone of Pharmaceutical Industry. It is the revenue generator for pharmaceutical Industry. The Regulatory Affairs department is an important part of the pharmaceutical companies.

More than 15 years span is required to develop and launch a new pharmaceutical product in the market. The Regulatory Affairs Agencies explains expenditure spent on each drug annually is $850 million in US. The Indian Pharmaceutical industry is one of the fastest growing industries in India, with a compounded annual growth rate (CAGR) of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years where India spends around $300 million, united kingdom $700 , Brazil $200 million , France $550, Italy $400. As per cabinet decision in June 2010 Japan amended a new policy i.e., Health power strategy through “Life Innovation” with an expenditure spent on each drug was $450 million.

Internally it cooperates with other department like drug development, manufacturing, marketing and clinical research. Externally, it is the key interface between the company and the regulatory authorities. Industrialized regulatory affairs are to drive compliance, speed to market, and cost efficiency.

Global Statistics:

·  Market revenue in terms of US$ Million for the period between 2013 and 2023 along with the compound annual growth rate (CAGR %) from 2015 to 2023 are provided for all the segments, considering 2014 as the base year.

·  Product development, research, and commercialization units are being set up at an increased rate across emerging economies owing to cheap resources and raw material costs.

·  The vast population base of Asia Pacific also makes it a lucrative regional market for the medical industry. These factors are acting in favor of the regulatory affairs outsourcing markets in these regions and will help strengthen the market’s foothold in the next few years.

·  As a result, the market for regulatory affairs outsourcing market in emerging economies will offer the most lucrative and sustained growth opportunities for the global market.

·  The market is expected to expand at a 15.8% CAGR in Asia Pacific and 11.1% CAGR across Latin America from 2015 to 2023.

·  The global regulatory affairs outsourcing market is expected to reach USD 12.4 billion by 2025.

Global Market Analysis for GMP:

The global market for pharmaceutical and biopharmaceutical contract manufacturing, research and packaging was $219.9 billion in 2012. This market is estimated to reach $242.2 billion in 2013 and $374.8 billion by 2018, a five-year compound annual growth rate (CAGR) of 9.1%.

GLOBAL Statistics:

• Global spending on medicines is forecast to reach nearly $1.3 trillion by 2018

• 21 pharmerging countries will increase their contribution to growth over the next five years and account for nearly 50% of absolute growth in 2018.

• The pharmerging markets will expand at a compound annual growth rate of 8-11% through 2018

• Total global spending will reach $1.3 trillion in 2018, an increase of $290-320 billion from 2013, driven by population growth, an aging population, and improved access in pharmerging markets.

• A compound annual growth rate of 4-7% on a constant currency basis, will be slightly higher than the 5.2% recorded over the past five years

Global Market Analysis for GCP:

"Good clinical practice", was developed under the auspices of the International Conference on the Harmonization of the Technical Requirements for the Registration of Human Pharmaceuticals (ICH process) and is applicable in the European Union, the United States and Japan.

The Global Clinical trial management system Market is expected to reach Significant Market Size by the end of the forecasted period and is expected to grow at a CAGR of ~15%.

IMS Market Prognosis 2012 predicted the pharma market in Asia (excluding Japan) to reach $350 billion by 2016 – $80 billion of this from China, but the majority from these other less talked about markets. This accounts for 30% of the $1.2 trillion that makes up the global pharma market. Each country’s government has recognized the opportunity this industry can bring to national development, and are therefore focused on supporting and investing in the sector.

 

To Collaborate Scientific Professionals around the World

Conference Date June 08-09, 2018

For Sponsors & Exhibitors

[email protected]

Speaker Opportunity

Supported By

Pharmaceutical Regulatory Affairs: Open Access Pharmacoeconomics: Open Access Advances in Pharmacoepidemiology & Drug Safety Research & Reviews: Journal of Pharmaceutical Quality Assurance

All accepted abstracts will be published in respective Conferenceseries International Journals.

Abstracts will be provided with Digital Object Identifier by


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