27/08/2014 Professional & Short Term Course
Covalent is a group of company which has services and operations in Clinical, Information Technology, Energy, consumer products, Power and Infrastructure.
Training @ Covalent:-
We arededicated to establish ourselves as ''A values-driven organization''. These values will continue to direct our growth and organization’s operation. “Covalent” values supporting the way like “Kreative”.
Regulatory Affairs(RA) Training or Course:-
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).
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).
Training Duration (Classroom/Online): 3-Months/2-Months
Training Fee: 20K/25k
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