Regulatory Affairs Training institutes in Hyderabad (Hyderabad)

Regulatory Affairs Training institutes in Hyderabad

Regulatory Affairs (RA)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. Drug discovery and development Worldwide regulatory agencies and their role 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 GLP s 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 advisory committee. Regulations of Drugs and cosmetics Act 1945 and its importance to Indian pharma industry. Recent regulatory changes in Indian DCGI and compiling dossiers for various DCGI submission Hands on workshops in next 15 days Word template of CTD structure. Hands on work of filling different regulatory forms in US EU India. Preparing for Regulatory interviews (Example interview questions will be provided). Communication skills. 2-3 seminars each of individual students to enhance their confidence and presentation skills. Explaining the real difficulties faced in a pharma industry and providing Corrective and Preventive Actions (CAPA).