FUTURE DEVELOPMENT AND CHALLENGES IN REGULATORY AFFAIRS (MEDICAL DEVICES AND VACCINES)

PROGRAMME DETAILS

Training Dates:  19 APR 2021 to 23 APR 2021
Batch Timings: 06:00 PM to 09.00 PM IST
 Duration:  15 Hours

WORKSHOP DAILY DURATION: 03 HOURS 

PROGRAMME FEES:

Training Cost: INR 9,000 + 18% GST extra =INR 10,620 (Including GST)
**Scroll Down For Key Topics, Trainer’s Profile, Programme Deliverables, Target Audience*

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Trainer Profile

 
  • Mr Kamlakar Sharma has more than 35 years of professional experience in Regulatory Affairs functions in major Indian / Multinational Pharma / Medical Device Company’s. In his last corporate role, he had served as Head, Regulatory affairs, Alcon Laboratories. Prior to that he was head of regulatory support, medical & research division, Pfizer India, followed by director, regulatory affairs, Bausch and Lomb India.
  • Mr Sharma has the expertise in major functions pertaining to the Regulatory Affairs of Pharmaceutical, Biologicals, Medical Device Industry including the Registration of New Drugs / Medical Devices. He is also working as Council Member for Pharmaceutical Medicines and Medical Devices for GLG Group USA and Regulatory Advisor for Pharmaceutical Medicine and Medical Devices projects for GUIDEPOINT USA.
  • During this professional journey, he had also been awarded with “Presidents Special Award for the year 2002” during the Annual Business Conference of Pharmacia for an “Outstanding Performance”. In the year 2006, he was awarded with “Certificate of Appreciation” Pfizer’s Medical & Research Division Achievement Award for outstanding performance”.
 
 
 
 
 
 

Key Concepts

  • A comprehensive study material for all the modules in soft copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.
  • Assignments for all the programme modules for continuous evaluation and guidance.
  • Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
 
 
 
  • At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
  • All learning and training delivery initiatives shall be conducted in English.

Eligibility

  • Experienced professionals in Quality Assurance / Pharmacovigilance / Clinical Trial Operations / Medical writing / Clinical data Management / Clinical SAS Programmers / Regulatory Affairs
  • Any degree in Pharma-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
 

Key Topics

 
  • Classification of Medical Devices as per new Medical Device Rules 2017.
  • Labelling of Medical Devices
  • Standards of Medical Devices.
  • Clinical Investigation of New Medical Devices – Correct Regulatory Filing & Handling of Regulatory Queries.
  • Regulatory Pathway – To obtain License to Manufacture a Medical Device in India for Marketing.
  • Regulatory Pathway – To obtain License to Import & Export of Medical Devices.
  • Medical Device Regulations – International Practices.
  • New Medical Device Regulatory Challenges, Complexities and Possible Remedies.
  • Regulatory Non-Compliance, Complexities, Remedy & How to Avoid It.
  • Regulatory Pathway for Vaccines:- Regulations, Approval Process, Post Approval Regulatory Compliance and Regulatory Challenges to New Vaccines
     
 
 
 
 
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