Course Description:

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.

Learning Objectives:

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

Course Outline:

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 Break
10:45 AM - 12:00 Noon The Biosimilar Comparability study overview
12:00 Noon - 1:00 PM Lunch
1:00 PM - 3:00 PM Analytical methods required in a Biosimilar Comparability study
3:00 PM - 3:15 PM Break
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 Break
10:00 AM - 12:00 Noon Lot release and Stability testing of Biosimilars

Meet Your Instructor

Nanda Subbarao
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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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $150 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

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We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

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After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

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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.
- Vice President

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