Biologics CMC Workshop: Current Trends, Future Trends and Regulatory Challenges - February 2020 (SOL

When:  Feb 26, 2020 from 9:00 AM to 3:00 PM (ET)

26 February 2020 (9:00 am–4:30 pm PDT)
27 February 2020 (9:00 am–3:00 pm PDT)
Biltmore Hotel and Suites
2151 Laurelwood Boulevard
Santa Clara, CA 95054

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

Location
Biltmore Hotel and Suites
2151 Laurelwood Boulevard
Santa Clara, CA 95054

Registration Fees
Registration to 27 January 2020
RAPS Members: $1,050
Nonmembers: $1,150

Registration from 28 January to 19 February 2020
RAPS Members: $1,150
Nonmembers: $1,250

Advance registration is required for this workshop. Participants are encouraged to register early. Onsite registrations are not accepted.

Registration Closes: 19 February 2020
Refund Deadline: 27 January 2020
RAC Credits: 12RAC recertification credits upon completion of the program
Will this meeting be recorded? No
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: 27 January 2019

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.

Program Contact

Nichelle Sankey
nsankey@raps.org
+1 301 770 2920, ext. 291

Area Airports
San Jose International Airport (SJC)

Cancellation

All cancellation requests must be submitted to raps@raps.org by 27 January 2020. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed for cancellation requests submitted by the deadline. After the deadline, RAPS will assess a 50% cancellation fee.

Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org by 12 February 2020.

If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.

NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.

Location

2151 Laurelwood Rd
Santa Clara, CA 95054-2754