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Regulatoryaffairs 2019

Regulatory Affairs 2019

Details of Regulatory Affairs 2019 Conference in USA:

Conference Name

Place

Date

Regulatory Affairs 2019

Houston, USA

March 20-21,2019

 

With the coordination of renowned speakers of Regulatory Affairs 2018 Conference series LLC Ltd is privileged to announce “9th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR” which is slated on March 20-21, 2019 in Houston, USA. We cordially invite all regulatory scientists, intellectual property rights (IPR) attorneys, researchers, industrialists, academicians in the fields of regulatory affairs, intellectual property rights, and medical devices to contribute their role towards the conference by sharing their research work, new strategies in the fields.

2019 Key ThemesRegulatory Affairs 2019 conference will focus on new strategies, amendments, innovations, developments in the fields of regulatory affairs, intellectual property rights and medical devices with the theme: “Current challenges of Pharmaceutical & Biopharmaceutical Industries in regulatory framework” which reflects new strategies in the field of regulatory affairs. This conference includes workshops, symposiums, special sessions, key note sessions, conducted by eminent and renowned speakers who excel in the field of regulatory affairs, medical devices, intellectual property rights which include the topics regulatory affairs in pharmacovigilance, clinical affairs & regulatory strategies, regulatory strategies and developments, penalties of regulatory Non-compliance, biologics & biosimilars, global regulatory intelligence, Impact of Brexit on regulatory framework, regulatory requirements in pharmaceuticals, regulatory challenges for medical devices, medical device and combination products regulation, Intellectual property rights etc. This International Regulatory Affairs Conference also encourages the active participation of Young Researchers, Students as we are hosting Poster Award Competition and Young Research Forum at the conference venue.

  • 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
  • Regulatory Enforcement & Inspection

Target Audience:

  • Regulatory Affairs experts
  • Clinical Research Associates
  • Medical Devices experts
  • Quality Assurance experts
  • Intellectual Property Rights attorneys
  • Scientists
  • Researchers
  • Academicians
  • Industrialists

Continent wise participation Analysis for Regulatory Affairs 2018 conference

Session/Tracks

Track 1: Regulatory Affairs

Regulatory Affairs profession was developed by the government regulatory bodies to regulate the safety and efficacy of products to protect the health of public. This was developed in all most all divisions of health care industry like pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, complimentary medicines etc. This profession involves development of new and existing products from early on, preparation and till submission to the relevant regulatory bodies of health authorities by inputting regulatory principles.

Regulatory Affairs is involved actively from early stage of development to post marketing activities of new and existing products. This department is one of the integral parts within the organization structure of pharmaceutical industry. Internally it collaborates at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the commercial industry which undergoes drug development to clinical research and the regulatory authorities.

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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.

Pharmacovigilance evaluates the adverse effects in turn speaking about the efficacy and safety data of particular drug product thus, collaboration of pharmacovigilance with regulatory bodies provides all the adverse reactions, safety data to regulatory authorities.

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.

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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.

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

Track 4: Regulatory Strategies and Developments

Regulatory strategies are formal documents that include series of regulatory activities to discover an innovative product or a modified product to market with business strategy for that product. This provides description and course to project team for the product being developed with identification of important regulatory elements which are addressed to market the product. Within a firm there are many regulatory strategists from different departments that involve all aspects of a drug and individuals with expertise in chemical synthesis, toxicology, biology, clinical and regulatory affairs, marketing, government affairs and reimbursement inputs into the regulatory strategy ensuring it is comprehensive.

Regulatory strategy document has three purposes, it acts as a:

  • 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

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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 Risk Based Monitoring. This includes penalties and activities associated with those penalties that are required to be undertaken because of noncompliance with regulation. Regulatory impacts that arise, up to the point that action is taken to respond to the suspicion of a specific instance of noncompliance, are included in RBM framework. This includes risk based frameworks that may target certain populations without a specific instance of suspicion. 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.

Recommended Conferences:

GMP & Pharma Audit 2019Drug Safety 2018BioPharma 2018Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory AuthorityMedicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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.

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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.

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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.

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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.

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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.

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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.

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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.

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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.

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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.

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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.

Recommended Conferences:

GMP & Pharma Audit 2019, Drug Safety 2018, BioPharma 2018, Drug delivery 2018

Related Conferences:

International Conference and Exhibition on Drug Safety & Pharmacovigilance, August 29-30, 2018, Toronto, Canada; 10th World Congress on Bioavailability & Bioequivalence, April 08-10, 2019 Abu Dhabi, UAE; 18th Annual Pharma Middle East Congress, November 05-07, 2018 Abu Dhabi, UAE

Related Societies in USA:

North Carolina Regulatory Affairs Forum, The Organization for Professionals in Regulatory Affairs, Regulatory Affairs Professionals Society, World Intellectual Property Organization

Related Societies in Europe:

European Policy for Intellectual Property

Related Societies in Asia-pacific:

National Health Regulatory Authority, Medicines Regulatory Authority, Drug Regulatory Authority, Drug Regulatory Authority of Pakistan, Cosmetics, Devices and Drug Regulatory Authority.

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.

Letter of Invitation

It's the delegate's responsibility to investigate the visa requirements for USA and to apply for a visa, if necessary. Individuals requiring an official Letter of Invitation from the conference organizers can request one by email by writing to us at [email protected]

To receive a Letter of Invitation, delegates, accompanying persons/children, student/post-doc/youth delegates and exhibitors must first register for the conference.

The registration fee minus a handling fee of USD 100 will be refunded after the conference if the visa was applied for in time and proof is shown that a visa could not be granted even though all requested documents were submitted. Refund requests must be made in writing and sent to the Regulatory Affairs 2019 via email.

All expenses incurred in relation to the conference are the sole responsibility of the delegate. The Letter of Invitation does not guarantee an entry visa to USA. However, the conference organizers will not directly contact embassies and consulates on behalf of delegates.

The deadline for requesting a Letter of Invitation is one month before travelling to USA.

 

Why to Attend

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.

Past Conferences

We gratefully thank all our wonderful Keynote Speakers, Speakers, Delegates, Students, Organizing Committee Members, Associations, Sponsors, Exhibitors and Media Partners for making our Past Pediatrics Conferences (during 2015, 2016 & 2017 in USA Region) the best ever!

  • 5th International Conference and Exhibition on Pharmaceutical Regulatory Affairs , August 03-05, 2015 Florida, USA
  • Venue: Hyatt Regency Orlando International Airport 9300 Jeff Fuqua Blvd
  • 6th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR, Sept 29-30, 2016 Orlando, USA
  • Venue: DoubleTree by Hilton Hotel Orlando Airport, 5555 Hazeltine National Drive, Orlando, FL 32812 , USA
  • ‚Äč7th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR, September 25-26, 2017
  • Venue: Doubletree by Hilton Chicago North Shore Conference Center, 9599 Skokie Blvd., Skokie IL 60077 Chicago, USA
  • 8th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR, June 08-09, 2018
  • Venue: Doubletree by Hilton Hotel Philadelphia Airport, 4509 Island Ave., Philadelphia, PA 19153

 

Mark your calendars for the upcoming conference; we are hoping to see you soon!

Regulatory Affairs 2019

 

 

Key Note Speakers

Past Conferences Keynote Speakers

We thank all our Honourable Keynote Speakers for their valuable presence, namely

 

Chairs/Co-chairs

Past Conferences Chairs/Co-Chairs

We extend our appreciation towards our Chairs and Co-Chairs of the sessions, namely

  • Ting-Chao Chou, PD Science LLC, USA
  • Hudson NakamuraGoias Eye Bank Foundation, Brazil
  • Michael Drues, Vascular Sciences, USA
  • Antonio Trejo DiazTeva Pharmaceuticals, Mexico
  • Rajiv MahendruB.P.S. Government Medical College for Women, India
  • Brian HillBrian Hill Consulting, USA
  • Mohammad R Khan, Synergex Consulting, Canada
  • Ramnarayan Randad, Food and Drug Administration, USA
  • Jelena Gankina, NPF Materia Medica Holding, Russia
  • Diadelis Remirez Figueredo, Devices and medical equipments (CECMED), Cuba
  • Eliana Silva De Moraes, ABVPS, Brazil
  • Eleonora Babayants, Galaxy Consulting LLC, USA
  • Joel Finkle, Acuta LLC, USA
  • Rashid Mahmood, Surge Laboratories Private Limited, Pakistan and more…

Moderator

Past Conferences Moderators

Conference series LLC Ltd expresses its gratitude to the conferences Moderators, for taking up the responsibility to coordinate during the sessions, we are indebted to your support, namely

  • Stephen Amato, North Eastern University, USA
  • Joel Finkle, Acuta LLC, USA
  • Raymond C Jagessar, University of Guyana and more…

Past Conference Report

Regulatory Affairs 2018

Past Reports  Gallery  

Regulatory Affairs 2017

Past Reports  Gallery  

To Collaborate Scientific Professionals around the World

Conference Date March 20-21, 2019

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 Conference Series LLC LTD International Journals.

Abstracts will be provided with Digital Object Identifier by