â€œHow much and How soon is the questionâ€ - Implementation of BMV Guideline 2018
Sponsored by: Syngene International Limited
- Bioanalytical Methods
- Biologics Development
Date: 3 October
Time: 3PM London/10AM New York
A Systematic approach to Regulated Bioanalysis
After 5 years of the draft document under consideration, the USFDA has released the final guidance on Bioanalytical Methods and Validations (BMV) on 24 May 2018. Compared to the 2001 or the 2013 draft guidance, the 2018 version is much more descriptive and takes into consideration the complex nature of immunoassays in support of biologics development. The efforts now should be channelled towards understanding the new requirements, recommendations and incorporating the guideline best practices into laboratory studies as soon as possible.
This webinar will focus on finer points of the guideline, compare critical recommendations with its older version to discuss implementation strategies for large molecule laboratories. This discussion will address key parameters of regulated Bioanalytical (PK/TK) assays for Biologics and Biosimilars in line with USFDA expectations.
Learning from this webinar will not only benefit the bioanalytical scientist but will also add significant value to the bioanalytical quality assurance teams to ensure validation studies are indeed fit for their intended purpose and in alignment with regulatory expectations.
Head, Large Molecule Bioanalytical Laboratory
Aparna Kasinath is currently Head and Test Facility Management, GLP Regulated Bioanalytical Laboratory for Large Molecules, Syngene International Limited, Bangalore, India supporting Large Molecule Bioanalysis for Regulatory filings.
Aparna has more than a decade of experience with PK, ADA and Nab assays for Biologics, and more than 15 years of experience in assays.
Aparna has a PhD from Sardar Patel University, Gujarat, India and was selected as a UNESCO fellow to the Czech Academy Of Sciences, Prague- as a part of her PhD program.
As an active member of various Bioanalytical Groups she strives to bring out the Bioanalytical Practices on to a Global Platform for effective Harmonization.
Key Learning Objectives
- Bioanalytical Method Validation 2018
- Key considerations
- Implementation strategies
- Guideline alignment
- Laboratory / R&D Management
- Laboratory / R&D Scientist
- R&D Management
- Heads and Bioanalytical Scientist staff at Large Molecule Laboratories
- Heads of Immuno-analytical Laboratories
- Heads of Biologics Immunoassay Laboratories
- Research Director