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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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 activities in the preparation of dossiers as well as an overview of some of the technical issues that must be addressed in biologic product development, registration, and lifecycle management.
Topics will include:
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.
Thursday, October 27, 2022
9:00-9:30 – Introductions and overview of class
9:30-10:00 – Introduction to biopharmaceuticals
10:00-10:30 - Biologics product characteristics and regulatory implications
10:30-10:45 – Break
10:45-11:00 - CMC regulation and guidances
11:00- 12:00 – Quality by Design, ICH 8-12
12:30-1:00 - Clinical Phase-Appropriate CMC
1:00-1:30 – Introduction to eCTD
1:30 - 2:15 – eCTD Strategy
2:15-2:30 - Break
2:30-3:30 - eCTD Strategy
3:30-4:00 – Break out - Review of CRL
4:00-4:30 – eCTD Strategy, Questions
Friday, October 28, 2022
9:00-10:00 – eCTD 3.2.S.3 Characterization and Impurities
10:00-10:45 – eCTD 3.2.S.4 Control of DS
10:45-11:00 – Break
11:00 – 11:30 – eCTD 3.2.S.4.3 and 3.2.S.5 through 7
11:30 - 12:00 – Breakout session
12:30-1:00 – Breakout session recap
1:00 – 1:30 - Drug Product considerations
1:30 – 2:30 - Appendices and Adventitious Agents
2:30 - 3:00 – Comparability and Biosimilars
3:00 – Questions and Answers
Registration fee includes:
Early Bird by 28 September 2022
Regular by 26 October 2022
5635 Fishers Ln
Rockville, MD 20852
EVEN Hotel Rockville - Washington DC Area, an IHG Hotel
1775 Rockville Pike
Rockville, MD 20852
A limited number of rooms is available at the rate of $119.00 + tax.
Book online at Even Hotel Rockville or by phone: 855.879.3836
Group Code: CMC
Reservations must be made no later than 11 October 2022.
Parking $14.00 a day for overnight parking at the hotel
Complimentary Parking for local attendees:
5635 Fishers Lane Garage - ParkChirp
RAPS will require proof of COVID-19 vaccination or proof of a negative PCR test taken within 24 hours of arrival in order to attend. Unvaccinated individuals or those unable to provide proof of vaccination or a negative PCR test will not be permitted to attend.
RAPS will continue to monitor any new developments and evaluate what is needed to ensure you are comfortable and we meet safely. We will keep all participants updated as we get closer to the event.
Participants must follow RAPS’ Be Well policy, which requires consent during registration by all attendees as a condition of on-site participation. This includes the stipulation that if you feel sick or are experiencing COVID-like symptoms prior to traveling or while on site, you will reconsider your participation at the event. To help ensure your personal safety and comfort, RAPS is committed to robust and transparent communications. We encourage all participants to monitor RAPS’ social media channels to receive the latest updates.
All cancellation requests must be submitted in writing to firstname.lastname@example.org. Cancellation requests received by Thursday; 13 October 2022 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 13 October 2022 will be non-refundable, except in cases of documented medical emergencies. RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.
By registering for this RAPS Event, you grant full permission to RAPS to capture, store, use, and/or reproduce your image or likeness, photograph, voice, and comments, and use such content in any and all media or forms by RAPS or third parties without compensation or notice, including for promotional or advertising purposes. You also waive any right to royalties or other compensation arising from or related to the use of the images, recordings, or materials. By registering, you release, defend, indemnify and hold harmless RAPS from and against any claims, damages or liability arising from or related to the use of the images, recordings or materials, including but not limited to claims of defamation, invasion of privacy, or rights of publicity or copyright infringement, or any misuse, distortion, blurring, alteration, optical illusion or use in composite form that may occur or be produced in taking, processing, reduction or production of the finished product, its publication or distribution.
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email email@example.com with the event title, name of the original registrant and the contact information for the new attendee.
Meeting Cancellation: RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email firstname.lastname@example.org.