Regulatory Affairs Training Hyderabad|Regulatory Affairs Onl

Groupware Training is offering Regulatory Affairs with real time faculties
Introduction to different types of Pharmaceutical products
Basic concepts on Rx, OTC, API, Starting material, DP/FP, Generics Vs Innovator drugs, Biologics Vs Biosimilars, Laws Vs Regulations Vs guidelines.
Approval process for each of the below products in US/EU/India: [covers development path, submissions, regulatory expectation for development, approval and market].
Post-market regulatory obligations.
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
ASEAN and BRIC regulations and registration process of Drugs and Biologics.
Different stages of interactions, briefing packages, responses and corrective measures during drug approval process with FDA.
PDUFA meetings and advisory committee meetings with US FDA, EU scientific advice.
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