RAPS Workshop: Implement Efficient Changes to Approved Biologic Manufacturing and Controls Using Ris

Changes are an inevitable part of drug product development and occur frequently even after licensure, when marketing approval has been received. For biologic drug products, such as recombinant proteins, vaccines and novel modalities, these postapproval changes are critical for continual improvement of the manufacturing process and implementing advanced controls. However, they are often seen by industry and regulatory agencies as a major risk and burden.

Multiple-year timeframes for regulatory approval have driven the recent finalization of various guidance documents, such as ICH Q12, entitled Technical and Regulatory Considerations for Pharmaceutical Product Lifecyle Management, along with other global guidance documents and industry efforts. These publications support a risk-based categorization approach to make the regulatory approval and notification procedures more efficient. Collaborations among drug manufacturers, regulators and third-party service providers over the years have built extensive knowledge to understand key factors of drug manufacturing correlated with risk. Against common assumptions, many of the manufacturing system and raw material changes that are typically considered major could actually be categorized as moderate and minor changes. During this workshop, case studies based on selected collaborations will be presented, highlighting a science and risk-based approach to foster effective manufacturing changes and improvements. In addition, filing of a post-approval change management protocol (PACMP), also known as a comparability protocol in the US, will be reviewed for different scenarios.

Registration Fees & Deadlines

Learning Objectives

• Define the risk categorization of a change and the regulatory notification procedure
• Utilize recent regulatory guidelines, along with utilizing process and product understanding, to help clarify decision-making for implementation of postapproval changes.
• Detail conditions to be fulfilled and supporting documentation needed for specific biologic drug manufacturing and control changes.

Who Should Attend?

Regulatory Affairs CMC, Quality Assurance, Manufacturing and Supply Chain Manager and Director levels

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.

Speakers

Janmeet S. Anant, RAC
Senior Regulatory Consultant, Millipore Sigma

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