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8th International Conference on cGMP, GCP & Regulatory Affairs, will be organized around the theme “Meeting standards of drug regulations & achieving GxP compliance”
Regulatory Affairs 2018 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Regulatory Affairs 2018
Submit your abstract to any of the mentioned tracks.
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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.
- Track 1-1Importance and scope in pharma industry
- Track 1-2Regulatory procedure manual
- Track 1-3Regulatory Compliance
- Track 1-4Good Regulatory Practices
- Track 1-5Conflicts and Solution Trends in Regulatory issues
- Track 1-6Drug Design and development for compliancing with Regulatory Policies
- Track 1-7Code of Federal Regulations
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.
- Track 2-1Overview of drug, biologic and device regulatory pathways
- Track 2-2Food, drug and cosmetic laws
- Track 2-3Generic drug submissions
- Track 2-4FDA and related regulatory agencies
- Track 2-5Regulatory Authorities
- Track 2-6NDA and ANDA filling
- Track 2-7Regulatory Authorities
- Track 2-8Vigi-base
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.
- Track 3-1Documentation
- Track 3-2USFDA, MHRA, EMEA
- Track 3-3NDA
- Track 3-4IND Application
- Track 3-5Clinical trials in emerging markets
- Track 3-6Key product-label attributes
- Track 3-7Regulatory risks
- Track 3-8Regulatory submissions and correspondence
- Track 3-9Pre-clinical and clinical studies
- Track 3-10The New EU Clinical Trial Regulation
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
- Track 4-1Role of QMS (Quality Management System) in Regulatory Compliance
- Track 4-2Product Registration & Submission
- Track 4-3Accelerating drug approval timelines
- Track 4-4Improving drug and vaccine safety
- Track 4-5Drug pricing mechanisms
- Track 4-6Dealing with higher registration and renewal fees
- Track 4-7Quality control and quality assurance
- Track 4-8Current Practices in Solving Complex Regulatory matters
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.
- Track 5-1Consumer Price Index (CPI)
- Track 5-2Civil Money Penalties
- Track 5-3Noncompliance
- Track 5-4FCPIAA, Federal Civil Penalties Inflation Adjustment Act
A 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.
- Track 6-1Legal Issues and BPCI Act
- Track 6-2Quality measures
- Track 6-3Intellectual Property Rights in Biosiimlars
- Track 6-4Regulatory requirements for Biosimilars
- Track 6-5New US-FDA draft Guidance on Interchangeability of Biosimilars
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.
- Track 7-1Role of global regulatory affairs
- Track 7-2Key regulatory functions and activities
- Track 7-3Global regulatory affairs organization
- Track 7-4Global regulatory agency interactions
- Track 7-5Global regulatory strategy
- Track 8-1Brexit effects on Pharmacovigilance and Protocols
- Track 8-2Brexit effects on Clinical Trials
- Track 8-3Exclusions and inclusions in regulatory affairs
- Track 8-4Pharmacoeconomic aspects of Brexit
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.
- Track 9-1Global guidelines for the development of biologics
- Track 9-2Trends in designing chemistry, manufacturing and controls (CMC) components of regulatory submissions
- Track 9-3Current Trends in Planning, Preparation and Delivering Regulatory Submissions
- Track 9-4FDA CDER and CBER review
- Track 9-5Speed Biologics development
- Track 9-6Global trend for Biologics
- Track 9-7Regulating regenerative medicine
- Track 9-8Cosmetics
- Track 9-9CTD, eCTD
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.
- Track 10-1Harmonization Initiatives and best practices
- Track 10-2Quality CMC/Harmonization
- Track 10-3ASEAN labelling harmonisation
- Track 10-4Audits and inspections
- Track 10-5Drug safety and good pharmacovigilance practices
- Track 10-6Regulatory enforcement & inspection
- Track 10-7Good manufacturing practices & good laboratory practices
- Track 10-8Current Regulations for labeling and Advertising of Medicinal products
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.
- Track 11-1Trade secrets
- Track 11-2Patents
- Track 11-3Copyright
- Track 11-4Industrial design rights
- Track 11-5Trademarks
- Track 11-6Trade dress
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.
- Track 12-1FDA regulation
- Track 12-2Pharmacoeconomics & outcomes research
- Track 12-3Compliance strategies
- Track 12-4Unique Device Identification (UDI) in the USA
- Track 12-5Identification of Medicinal Products (IDMP) in Europe
- Track 12-6The New EU Medical Device Regulation
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.
- Track 13-1Medical device safety
- Track 13-2Governmental regulation of medical devices
- Track 13-3Global harmonization task force (GHTF)
- Track 13-4Clinical trial design for medical devices
- Track 13-5Standards
- Track 13-6Optimizing the use of regulatory resources
- Track 13-7Priorities on the international agenda
- Track 13-8Code of federal regulations
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 GCP, GLP 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
- Track 14-1Global regulatory Strategy
- Track 14-2Strategic drug development and regulatory strategy in USA
- Track 14-3Strategic drug development and regulatory strategy in Europe
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.
- Track 15-1Information on Compounding
- Track 15-2Drug compliance programs
- Track 15-3FDA guidance for clinical investigations
- Track 15-4Nicotine-containing products
- Track 15-5Newly added guidance documents
- Track 15-6PLR requirements for prescribing information
- Track 15-7Regulatory guidance drug registration and listing
- Track 15-8Regulatory guidance drug registration and listing
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.
- Track 16-1Pharmaceutical cGMPs for the 21st Century
- Track 16-2EU-GMP guidelines (European union-GMP guidelines)
- Track 16-3WHO-GMP guidelines (World health organization-GMP guidelines)
- Track 16-4 GMP for active pharmaceutical products
- Track 16-5GMP for biopharmaceuticals
- Track 16-6cGMP quality principles for biologics and biotechnological products
- Track 16-7Licensing in pharmaceutical production & GMP documentation
- Track 16-8Issuance and retrieval of GMP records
- Track 16-9Cancellation of GMP records
- Track 16-10Good Documentation Practice (GDP)
- Track 16-11Role of GxP in medical and food industries
- Track 16-12Good Engineering Practice (GEP)
- Track 16-13Good Auditing Practice (GAP)
- Track 16-14Good Review Practice (GRP)
- Track 16-15Role of GxP and c GxP in biopharmaceutical Industry
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.
- Track 17-1Design, monitoring, and control of manufacturing processes and facilities
- Track 17-2Maintenance, calibration and validation of equipment
- Track 17-3Role of qualified person and quality Indicators in GMP
- Track 17-4Reliability and reproducibility of processes
- Track 17-5Quality management systems
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.
- Track 18-1Role of ICH in designing GCP principles
- Track 18-2Principles of GLP in vitro Studies
- Track 18-3OECD guidelines for the testing of chemicals
- Track 18-4Good Laboratory Practices (GLP) for Pre-Clinical Testing
- Track 18-5IEC-GCP regulations
- Track 18-6Pre-clinical trails
- Track 18-7Clinical trails
- Track 18-8SAS programming, usage in pharmaceutical industry
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.
- Track 19-1GMP auditing compliance software
- Track 19-2Software quality control
- Track 19-3Regulatory compliance software
- Track 19-4cGMP software systems
- Track 19-5GxP (GMP, GCP & GLP) software systems
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.
- Track 20-1Hazard analysis and critical control points (HACCP)
- Track 20-2Quality control in a typical food processing system
- Track 20-3Cleaning, disinfection and hygiene
- Track 20-4Validation practices in the food industry
- Track 20-5Current food industry good manufacturing practices
- Track 20-6Food, drug and cosmetic act (FDCA)