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RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.
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 PDT) 30 September 2020 (9:00 am–3:00 pm PDT)
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.
Faculty
Patricia Cash, PhD, Independent Biotechnology Consultant
Joseph Quinn, Biologics Regulatory Consultant
Registration Fees Registration to 30 August 2020 RAPS Members: $800 Nonmembers: $900
Registration from 31 August to 22 September RAPS Members: $900 Nonmembers: $1,000
Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted.
Registration Closes: 22 September 2020 Refund Deadline: 30 August RAC Credits: 12 RAC recertification credits upon completion of the program
Proof of Attendance: An electronic letter of attendance will be sent upon request.
Program Schedule
Day One (9:00 am – 4:30 pm)
Day 2 (9:00 am - 3:00 pm)
NOTE: The agenda may vary based on changing requirements.
Program Objectives
Who Should Attend
This program will benefit mid-career regulatory professionals in CMC working in development, registration and post approval lifecycle management for biologic/biosimilar products. CMC SMEs will gain value in learning the regulatory implications of product development. There are no prerequisites for participation.
If it is your preference, please use the registration form 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.
Questions? Call RAPS Solutions Center at +1 301.770.2920, ext. 200.
Refund Deadline: 30 August 2020
Other Information
Please note that 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.
Cancellation
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 raps@raps.org. Due to uncertainty surrounding the COVID-19 situation, RAPS will allow substitutions up to the first day of the event.
Program Contact
Nichelle Sankey nsankey@raps.org +1 301 770 2920, ext. 291