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This workshop is currently sold out. If you would like to receive an email notification when this workshop is offered next, please complete the form at raps.realmagnet.land/cmc-september-2020-lead-gen.
In order to provide you a level of certainty in planning in the face of the COVID-19 situation, this event is now being delivered online as a virtual event. We are working with our instructors to ensure that the same learning objectives and quality of the education will be delivered regardless of this modification. RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates
29 September 2020 (9:00 am–4:30 pm EDT)
30 September 2020 (9:00 am–3:00 pm EDT)
Ensure your manufacturing process consistently produces safe and effective biologics.
All stages of the drug development life cycle require the proper adherence to chemistry, manufacturing and control (CMC) regulatory requirements. Join this two-day workshop for an introductory overview of CMC requirements and best practices associated with biologic and biosimilar products, with emphasis on requirements in the US, Europe and other highly regulated regions.
The class is designed to orient professionals, managers and scientists responsible for biopharmaceutical CMC development in the preparation of dossiers as well as an overview of some of the technical issues that must be addressed in biologic product development and registration.
Topics will include:
Registration from 31 August to 22 September
RAPS Members: $900
Advance registration is required for this workshop. Participants are encouraged to register early.
If it is your preference, please use the registration form link below to register by mail, email, or fax. A RAPS online account will be created to complete your purchase if you are not a member or past customer.
Registration Closes: 22 September 2020
Refund Deadline: 30 August
Day One (9:00 am – 4:30 pm EDT)
Day 2 (9:00 am - 3:00 pm EDT)
NOTE: The agenda may vary based on changing requirements.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Due to uncertainty surrounding the COVID-19 situation’s impact on travel our standard cancellation fees will be waived. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months.
Substitutions may be accepted with written approval from RAPS and must be submitted to firstname.lastname@example.org. Due to uncertainty surrounding the COVID-19 situation, RAPS will allow substitutions up to the first day of the event.
Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200.