Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, Biologics and functional foods). Most companies, whether they are major multinational pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments of Regulatory Affairs professionals. The success of regulatory strategy is less dependent on the regulations than on how they are interpreted, applied, and communicated within companies and to outside constituents. Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. The drug development process is a lengthy, complex and extremely costly albeit necessary process. Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug. . The course is meant for Graduates and Post Graduates, employed plus yet to be employed candidates keen on taking Regulatory affairs as their career choice.
Module 1 : : Introduction to Global Regulatory Authorities for pharma and healthcare industries
Module 2 : Drug Development Process, Clinical Trials and related norms and regulations
Module 3: GMP and other good practices
Module 4: Documentation of drug trials and regulatory filings in US, Europe, UK, India, Japan, Canada, Australia, South Africa, etc.
Module 5: Quality Assurance and Drug Regulations, ICH and WHO guidelines
Module 6: Dossier preparation in CTD format, eCTD submissions
Module 7: Healthcare Industry IPR, Patents, copyrights and Trademarks
Module 8: Pharma and Healthcare products- Marketing, Import and Export regulations
Module 9: Compliance guidelines, Govt. Audits (FDA, MHRA, PMDA, TGA, DCG, etc) and Breach reports
Module 10: Industry specific case studies
ANDA, NDA, INDA filing - Drug development process and its filing - Conventional dossier preparation - Preparation and filing of DMF - Preparation of CTD/eCTD dossiers for submission in regulatory agency - Preparation of clinical trial protocols and final clinical trial reports - Preparation of an IMPD for EU submission - Regulations in different countries and its filing process - Filing and preparation of Indian patent as per regulatory perspective - Preparation of GMP compliance checklist - Documentation for inspections and audits After completion of the course, participant is expected to have in-depth knowledge and up-to-date understanding of concept of generic drug and innovator, drug discovery and development, Regulatory strategy, approval process of all regulatory filings in various countries, filing process of IND, NDA and ANDA, IMPD, and Investigator Brochure (IB), DMF, US Hatch Waxman Act and code of federal regulations (CFR), US registration for foreign drugs, Europe IMPD, marketing authorization application (MAA), Centralized procedure, bio equivalence and drug product assessment-in vivo, Manufacturing and Controls (CMC) and their regulatory importance, Submission of global documents (CTD/eCTD), Filing process in India-IND, NDA, Clinical trials (Schedule Y) etc.
The course is designed in such a way to provide industrial level education regarding the applicable laws and regulations. It focuses on laws and regulations which a healthcare industry must comply to sell their product effectively in the market. The course also provides the knowledge of filling of information regarding new drug development, manufacture, control, stability studies, packaging, labeling etc. with regulatory agencies in a prescribed format.
All those who have completed their Graduation or Post Graduation/ Pharma / PhD are eligible to enroll for the course. As this course is truly professional and industry oriented, experienced individuals worked in any sector (production, processing, quality, trial, R&D etc.) in the healthcare industry (Food manufacturing, Food Ingredient and Additive processing, Drugs manufacturing , Medical Device, Ayurvedic, Pharmaceutical Industry Regulation, Clinical Research, Homeopathic or Ayurvedic Medicine Manufacturing, Cosmetic Manufacturing, Biotechnology) can also seek benefits of the course.