Biosimilars Analytical Characterization and Comparability Studies
Dr. Nanda Subbarao, Senior Consultant, Biologics Consulting Group
Coming soon.. Please contact customer care for new schedule
Analytical Strategy is a critical element of Biosimilar product development plan. A comprehensive Analytical package which meets current regulatory expectations will minimize the amount of clinical studies and therefore control costs of the Biosimilar development program.
This is a rapidly evolving topic and the industry needs to keep up with the current expectations. The draft Revision1 of the EU Biosimilar Quality guidance was issued in May 2012 and is currently open for comments. The FDA guidance on Quality Considerations in Demonstrating Biosimilarity To a Reference Protein Product is expected this year. Other regions of the world continue to publish Biosimilar Guidance and their revisions and several scientific publications which present the industry point of view have been published recently.
This workshop will provide the audience with:
- An overview of the current status of Global Biosimilar Guidance with a focus on the Analytical Package required for a Biosimilar product.
- The Analytical comparability studies currently required for comparison of the Reference Product with the Biosimilar will be discussed.
- The Analytical methods and specifications required for both comparability studies and lot release and stability studies will be addressed.
Who will Benefit:
- R&D chemists, supervisors and managers
- Regulatory Affairs personnel
- QC chemists, supervisors and managers
- QA Managers and personnel
|DAY ONE — Thursday, April 4, 2013
|8:30 AM - 9:30 AM
||Introduction and overview of the Global Biosimilar guidances
|9:30 AM - 10:30 AM
||The Reference Product
|10:30 AM - 10:45 AM
|10:45 AM - 12:00 Noon
The Biosimilar Comparability study overview
|12:00 Noon - 1:00 PM
|1:00 PM - 3:00 PM
Analytical methods required in a Biosimilar Comparability study
|3:00 PM - 3:15 PM
|3:15 PM - 5:00 PM
||Analytical methods required in a Biosimilar Comparability study
|DAY TWO — Friday, April 5, 2013
|8:30 AM - 9:30 AM
||Specification setting for Biosimilars
|9:30 AM - 10:00 AM
|10:00 AM - 12:00 Noon
||Lot release and Stability testing of Biosimilars
Meet Your Instructor
Senior Consultant, Biologics Consulting Group
Dr. Subbarao received her Ph.D. in Bio-organic Chemistry from the Indian Institute of Technology, Bombay, India. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. She has extensive experience in evaluation of analytical methods and method validation for products ranging from pre-clinical to clinical and commercial phases.
She is an ASQ Certified Quality Auditor with expertise in setup of cGMP/GLP complaint Quality Systems for laboratory and stability programs as well as upgrade of existing Quality Systems for products during development and in commercial phase. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She serves on the American Association of Pharmaceutical Sciences, Stability Focus team Steering Committee and is the current Regulatory Sciences Lead for National Biotechnology Conference Programming Committee.
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What past attendees say about ComplianceOnline Seminars
The presenter, Nanda, was knowledgeable and brought up some interesting challenges faced when dealing with OOS, stability and method validation activities. I felt the entire seminar was relevant to my job, which is a rarity. I plan on using the material and ideas from the seminar to evaluate some of the approaches we are currently taking. I felt I could have used a little more time listening/ talking with the presenter. I was also impressed that Nanda responded quickly to a question I had after the seminar via e-mail.
- QA Specialist, Stiefel, a GSK company
Nanda’s In-Person Seminar was one of the best seminar I attended. Many time we look at work place as the best place to work and we ignore the minor and major improvements that could be done in the facility. After attending the seminar I look at my work place as an Auditor and I definitely see the potential improvement area. In future I would like to attend more seminars with ComplianceOnline.
- QA/QC Supervisor, Xttrium Laboratories, Inc.
I found this seminar to be very informative and educational. Dr. Subbarao provided expert guidance on key industry topics and practical advice on ways to maintain compliance. She was engaging and a very effective speaker. I would recommend this class with Dr. Subbarao.
- Vice President - Regulatory Affairs/Quality, Inhibitex Inc.
I've attended quite a few seminars by different training providers but ComplianceOnline was by and far the best - the courses are well designed and up to date with the latest developments and the support staff are always helpful, ready to answer your queries.
- Chief Executive Officer
The instructor was not only active and helpful during the seminar and workshop, but was available to answer resulting queries after the event as well.
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