REGULATORY AFFAIRS (MPH 104T)

A Regulatory Affair is a unique synergy of internal departments of an industry with the regulatory bodies, which starts with the conceptualization of the product to be developed by that industry, till the marketing of that product. It is a very important and salient feature of pharmaceutical product development. This chapter provides an insight into the importance of regulatory affairs, regulatory requirements for product approval, and documentation in pharmaceutical industry, with a special mention of the master formula record, drug master file, and distribution records.

The chapters of the books provide an overview of introduction to regulatory affairs field, information of different regulatory authorities, how these professional works, different roles, and responsibilities of regulatory affairs professional. This book also gives information about different skills required for regulatory affairs career and employment opportunities exist in various sectors. We cover typical tasks; required skills; the ins and outs of the submission process; vital knowledge you’ll need to have; and much more. Lost in a sea of acronyms? We’ve got you covered. Not really sure how regulatory fits into pharmaceutical development? We explain the process.

Following Chapters are including:

1. Documentation in Pharmaceutical industry
2. Regulatory requirement for product approval
3. CMC, post approval regulatory affairs
4. Nonclinical drug development
5. Clinical trials