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:
- Biological product characteristics
- CMC regulations and guidance applicable to biologics
- Quality by Design
- Adventitious agents risk management
- Source material, cell & seed banks
- Upstream and downstream processing
- Formulation and final product production
- Characterization and testing
- Demonstrating comparability
Registration Fees & Deadlines
20 November 2023 – 10 September 2024: Member $825 |Nonmember $970
11 September 2024 – 10 October 2024: Member $970 |Nonmember $1,150
Learning Objectives
- Be familiar with various types of biologic products and their structural/functional characteristics
- Be able to distinguish phase-appropriate regulatory agency expectations associated with biologics characterization, development, production, and testing
- Be familiar with best practices in establishing a comprehensive chemistry, manufacturing, and control (CMC) regulatory strategy for application to the lifecycle of biological products
- Be familiar with Quality by Design principles as they relate to development, manufacturing, characterizations, and testing of biologic products
- Translate an effective biologics CMC strategy into effective regulatory submission content for biological products, including all sections of module 2 and 3 of the CTD.
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.
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Agenda
Day 1 9:00 am – 9:30 am | Introduction to Biopharmaceuticals |
9:30 am – 10:00 am | Biologics Product Characteristics and Regulatory Implications |
10:00 am – 10:30 am | CMC Regulation and Guidances |
10:30 am – 10:45 am | Break |
10:45 am – 11:30 am | Quality by Design, ICH 8-12 |
11:30 am – 12:00 pm | Clinical Phase - Appropriate CMC |
12:00 pm – 1:00 pm | Lunch |
1:00 pm – 1:30 pm | Introduction to eCTD |
1:30 pm – 2:15 pm | eCTD Strategy S.1 |
2:15 pm – 2:30 pm | Break |
2:30 pm – 3:00 pm | eCTD Strategy S.2 Upstream |
3:00 pm – 3:30 pm | eCTD Strategy S.2 Downstream and Formulation |
3:30 pm – 4:00 pm | Break out - Review of CRL |
Day 2
9:00 am – 10:00 am | eCTD 3.2.S.3 Characterization and Impurities |
10:00 am – 10:30 am | eCTD 3.2.S.4 Control of DS |
10:30 am – 10:45 am | Break |
10:45 am – 11:45 am | eCTD 3.2.S.4.3 and 3.2.S.5 through 7 |
11:45 am – 12:00 pm | Breakout Session - Review of CRL part 2 |
12:00 pm – 1:00 pm | Lunch |
1:00 pm – 1:15 pm | Report Back from Review of CRL part 2 |
1:15 pm – 1:45 pm | Drug Product Considerations |
1:45 pm – 2:15 pm | Appendices and Adventitious Agents |
2:15 pm – 2:30 pm | Break |
2:30 pm – 3:30 pm | Comparability and Biosimilars |
3:30 pm – 4:00 pm | Question and Answer |
***Agenda is subject to change
Speakers
Pat Cash
Analytical/Regulatory Expert in Biotechnology, Independent Consultant
Joseph Quinn
Biopharmaceutical Regulatory Affairs Consultant & Educator
Cancellations and Refunds
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 to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
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 support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org