RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Biologics CMC Workshop: Current Trends, Future Trends and Regulatory Challenges - September 2020

12.0
RAC Credits
Tuesday, 29 September 2020 (9:00 AM) - Wednesday, 30 September 2020 (3:00 PM) Eastern Time (US & Canada)

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.

    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

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)

  • Types of biological products (therapeutic proteins, antibodies, drug-antibody conjugates, vaccines, gene therapies, cell-based therapies)
  • Biological product characteristics and corresponding regulatory implications
  • Biological CMC regulation and guidance framework
  • Clinical-phase appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars
    • Cell substrates & source materials, cell banks
    • Upstream processing

Day 2 (9:00 am - 3:00 pm)

  • Clinical-phase appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars (continued)
    • Downstream processing
    • Final product formulation
    • Characterization
    • Testing & specifications
  • Adventitious agents risk management
  • Demonstrating comparability & comparability protocols

NOTE: The agenda may vary based on changing requirements.

Program Objectives

    At the conclusion of this workshop, participants should:
  • 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.

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

Register