Regulatory Affairs Training
Introduction to different types of Pharmaceutical products:
- Medical devices
Basic concepts on Rx, OTC, API, Starting material, DP/FP, Generics Vs Innovator drugs, Biologics Vs Biosimilars, Laws Vs Regulations Vs guidelines.
Drug discovery and development.
- Drug discovery stages and preclinical development
- Target identification, selection, validation, hit and lead identification, optimization, clinical candidate selection.
- Preclinical and clinical development
- Drug product approval process for new and generic drugs (US/EU/India)
Worldwide regulatory agencies and their role
- Key country agencies like India, US, Canada, EU, Australia and overview of their regulations
- Role of ICH, relevant ICH guidelines in QSEM and WHO in pharma industry (US/EU/India)
Approval process for each of the below products in US/EU/India: [covers development path, submissions, regulatory expectation for development, approval and market].
- Drugs (new and generic BA/BE)
- Biologics (new and biosimilars)
- Medical devices
- Combination products (drug-drug and drug-device) Vs FDC
- Orphan drugs
Post-market regulatory obligations.
- Responsibilities and reporting of annual reports, post approval changes,Pharmacovigilance, post approval clinical studies and managing the outcomes.
- Advertising and labeling requirements
GLPs: 21 CFR 58 -The History of GLP, The Idea behind GLP, The Areas of Application, The Pillars of Good Laboratory Practice, Where Can GLP be Profitably Applied?, Indian GLP and International GLP.
CMC topics: GMP (US/EU/Indian/ PIC), Preformulation studies (Drugs and Generics), ICH Q 7 guideline, 21 CFR 210 and 211, Medical device CE marking and ISO certifications.
Audits, pre and post approval Inspections, handling post inspection/ audit queries.
Collecting, organizing and compiling various regulatory submissions in compliance with the applicable regulations:
- IMPD/DMF (types of DMF)/ASMF
- PMA and 510K
- CTD and eCTD organization