Drug Regulatory Affairs

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Drug Regulatory Affairs

Drug Regulatory Affairs (DRA) is involved in all stages of drug development, drug approval, and marketing Regulatory Affairs at early pre-marketing and post-marketing stages. DRA Professionals provide planned and operational direction and support to advance the development and release of safe and effective drugs or devices globally.

Learning objectives

This course provides in-depth knowledge and up-to-date understanding of the concept of generic drug and innovator, drug discovery and development, Regulatory strategy, the approval process of all regulatory filings in various countries, filing process of IND, NDA and ANDA, IMPD, and the following:

  • Requirements for drug approval in Europe, the United States, and Canada.
  • The structure of marketing authorization, according to the CTD.
  • Knowledge of how different regulatory procedures work.
  • Drug approval procedures in Europe and the United States.
  • Required documents and timelines.
  • Understanding differences between Europe and the United States.
  • Ability to communicate with regulatory support functions.



Curriculum/Services


  • Introduction to RA profession.
  • Overview of the Drug Development Process.
  • ICH & Regulatory landscape.
  • Common Technical Document (CTD overview) - Dossier.
  • Regulatory System in Europe.
  • Drug labelling Regulations in Europe.
  • Regulatory System in the US (FDA).
  • US Drug labelling.
  • Drug Substance Registration.
  • Regulatory System in Canada (Health Canada).
  • Formulation or Product development.
  • Biologics Submissions.
  • Life Cycle of Drug Product.
  • Drug Registration with Rest of the World (ROW).
  • Dossier preparation in pCTD and eCTD format.
  • ICH Quality Guidance and its importance.
  • Performance evaluation.



Requirements


  • Any degree in Pharm-D / B. Pharmacy/ M. Pharmacy / Pharmaceutical Sciences.
  • Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS, etc.
  • Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology, etc.
  • Any degree in Chemistry / Biostatistics / Bioinformatics.
  • Any degree in Nursing / Allied Health.
  • Students in their final year of graduation for the above courses are also eligible to apply.

If you wish to learn more about Drug Regulatory Affairs, then we are here to guide you.

Download the course pdf for a detailed understanding before you begin your Drug Regulatory Affairs training with us!