Risk, Challenges and Future Development in Regulatory Affairs
Training focus on current regulatory requirements for Clinical Trials, New Drugs, Generic Drugs including Biological and Vaccines; performing risk analysis, to mitigate and manage risks, and also ensuring compliance with regulatory requirements.
This 15 hours training by one of India's best known regulatory expert is designed for senior management, managers, regulatory affairs professional and other professional staff .
Duration : 9 hours ( Molecules & Biologicals ), 6th to 8th April, 2021
Time : 5.30 pm to 8.30 pm IST ( 7 am to 10 am EST)
Mode of training : Online LIVE (via ZOOM)
Course Fee :
9000 INR for professionals registering from India
250 USD for professionals registering from outside India
Course Content :
Molecules and Biologicals / Vaccines ( 9 hours )
1. Regulatory Non-Compliance, Complexities, Remedy and How to Avoid It.
2. Which are the various online forms required for an approval of-
> New Drugs / Investigational New Drugs (IND)
>Clinical Trials
>Generic Drugs
3. Correct Regulatory Filing - Regulatory Pathway and Documents requirement including CMC documents for Marketing Authorisation of:-
>New Drugs
> Generic Drugs - Bio-availability (BA)& Bio-equivalence (BE) Study.
4. Regulatory requirements for Import / Marketing of:-
> New Drugs
> Clinical Trial
> Generic Drugs
5. Salient features of New Drug Clinical Trial Rules (NDCT) 2019 - what is new in NDCT- 2019
.
6. International Practices including USFDA, EU and MHRA
Biological / Vaccine
Regulatory Pathway for Biologicals and Vaccines:-
> Regulations
> Approval Process
> Post Approval Regulatory Compliance
> Regulatory Challenges to New Vaccines / Biologicals Development
Trainer's Profile :
Mr Kamlakar Sharma
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".
Please send your name, company designation, contact no and email to admin@scientiabio.com to register and call us at +91 804169 2453 / +91 9945318216 for any query or registration help.