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Location
This event will be held at Courtyard Boston-Cambridge Hotel.
Attendees will receive a discounted rate for parking of $21 for the day.
If you need to book a room, please visit their website or call 617-492-7777.

8:30 AM  Registration & Light Breakfast

9:00 AM Welcoming Remarks
Regulatory Expectations and Industry Guidance for E&L Studies
Andrew Blakinger, Manager, Extractables & Leachables Testing, Eurofins BioPharma Product Testing

9:45 AM
Seamus O'Connor, Ph.D., Associate Director Analytical Sciences, Regeneron Pharmaceuticals

10:30 AM
Coffee and Networking Break

10:45 AM Material Qualification Challenges for Combination Products
Cheryl Stults, Ph.D., C&M Technical Consulting

11:30 AM
Meng Xu, Research Scientist, Bristol-Myers Squibb

12:15 PM Complimentary Lunch

1:15 PM
Allan W. Ader, Ph.D., DABT, Managing Director, SafeBridge Consultants, Inc.

2:00 PM
2:45 PM
Snack and Networking Break

3:15 PM
3:45 PM
Desmond Hunt, Ph.D., Principle Scientific Liaison, USP


Cancellation Policy
If you need to cancel your registration for any reason, please contact us by September 12, 2019.
Cancellations after September 12, 2019 or no-shows will be billed a $100 cancellation fee.

Join a select group of industry colleagues for a complimentary full day seminar focused on extractables and leachables testing for drug products and medical devices, including:

  • Insights on current and upcoming regulations.
  • Best practices and strategies for establishing an extractables study design from experienced scientists.
  • Case studies from industry experts.

Agenda
This full day in person seminar will begin at 8:30 am and end at approximately 4:30 pm.  A light breakfast and lunch buffet will be provided to attendees.
Current Sessions Include:
  • Improving Leachable Study Quality and Efficiency Using Strategically Chosen Time and Storage Conditions
  • Appropriate Scientifically-Defensible Approaches to Assessing the Toxicity of Extractables and Leachables in Drug Products: Using All the Tools Available
  • Design of Leachable Studies for Platform Liquid Drug Products: Leveraging a Bracketing Approach
  • E&L Risk Mitigation Strategies for the use of polymeric consumables for manufacturing of Anti-Sense Oligonucleotides
  • USP Update on Packaging Standards: Revisions and Developments
We are still finalizing some details for our sessions and speakers and will publish the final agenda soon.

Location
This event will be held at Courtyard Boston-Cambridge Hotel.
Attendees will receive a discounted rate for parking of $21 for the day.
If you need to book a room, please visit their website or call 617-492-7777.

Cancellation Policy
If you need to cancel your registration for any reason, please contact us by September 12, 2019.
Cancellations after September 12, 2019 or no-shows will be billed a $100 cancellation fee.

Our event is full and registration is closed.