RAPS Workshop: Biologics CMC: Phase Appropriate Development (test)

With an emphasis on the product development challenges and regulatory expectations in the US, Europe and other highly regulated regions, this virtual 2-day workshop provides an in-depth study of the chemistry, manufacturing and control (CMC) product development requirements and best practices associated with biopharmaceuticals.

Specifically designed for RA/QA professionals, managers, development scientists and others responsible for biopharmaceutical CMC development and preparation of dossiers, this in-depth discussion will take a regulatory approach to the technical issues that arise during biopharmaceutical product development and registration.

Topics will include:

Biological Product Development From Early Phase to Commercialization
Source Material
Cell & Seed Banks
Upstream and Downstream Processing, Formulation and Final Product Production
Characterization and Testing
Setting Specifications at Early and Late Stages
Demonstrating Comparability
CMC Regulations and Guidance Applicable to Biologic products
Adventitious Agents Risk Management

Learning Objectives

At the conclusion of this workshop, participants should:

Be familiar with various types of biologic products and their structural/functional characteristics
Understand development phase-appropriate regulatory agency expectations associated with biologics characterization, development, production and testing
Understand best practices in establishing a comprehensive chemistry, manufacturing, and control (CMC) regulatory strategy for application to the lifecycle of biologic and biosimilar products
Understand the lifecycle aspects of process development, manufacturing, product characterization, specification setting and testing of biologic products
Translate an effective biologics CMC strategy into effective regulatory submission content for biologic and biosimilar products

Who Should Attend?

This program will benefit early, mid-career, and senior scientists, subject matter experts (SMEs) regulatory and quality professionals in CMC working in development, registration lifecycle management for biological products. There are no prerequisites for participation. It is recommended that the Workshop: Biologics CMC: Regulatory Challenges and Trends be taken prior to this course for early career SMEs.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Agenda

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 [email protected]. 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 [email protected] with the event title, name of the original registrant and the contact information for the new attendee.