Regulatory Affairs Training in Hyderabad is a unique mixture of science and management to achieve a commercially important goal within a drug-development organization. Regulatory Affairs takes care of Development plan, supervising-writing / reviewing and assembling and submission management. They give strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole.
By attending this course you will gain an overview of regulatory procedures required to register products in india and the regulatory activities that need to be complied with to keep products on the market. Pharma and safety reporting will be covered as well as licence variations and the commercial aspects of pharmaceutical products. The potential impact of Brexit will also be discussed. The course will provide a thorough grounding in the subject of regulatory affairs training in hyderabad and enable you to perform in your role more effectively.
This course is specifically designed for anyone working in regulatory affairs including personal assistants, secretaries, administrators and any member of support staff wishing to gain a greater understanding of regulatory affairs in the pharmaceutical industry. It is also suitable for those who interface with the regulatory affairs function and who provide support to the regulatory procedures and activities.
Topic 1: Introduction to RA
Topic 2: ICH guidelines
Topic 3: CTD – eCTD
Topic 4: Drug Development Process and Product development.
Topic 5: Generic Drugs
Topic 6: Drug approval procedure in US
Topic 7: Drug approval procedure in Europe
Topic 8: Discussion on deficiencies received from authorities and how to address the quires effectively.
Topic 9: Project work with hands on experience in dossier compilation activity.
Topic 10: Resume preparation and interview questions.
Regulatory Affairs Training in Ameerpet
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