TS2A: REGULATORY REQUIREMENTS ACROSS THE PRODUCT DEVELOPMENT LIFECYCLE

MONDAY, AUGUST 12 AND TUESDAY, AUGUST 13
DAY ONE: 1:00 – 5:00 PM | DAY TWO: 8:00 AM – 5:00 PM

Waterfront 1C

Instructor:

Christine Vessely, PhD, Senior Consultant, Biologics Consulting Group

The successful development of a pharmaceutical product requires not only good science, but also compliance with FDA regulatory expectations. This course will include a comprehensive review of the Chemistry, Manufacturing and Controls (CMC) section of regulatory filings, with a focus on phase appropriate requirements. The level of detail that must be included in the filing will be discussed as well as systems and controls that must be in place in the manufacturing setting. Topics such as process development, analytical development, Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) will be discussed in the context of the stage of drug development. Regulatory strategies for navigating the path to approval will also be discussed. This course is intended to provide participants from all facets of the pharmaceutical and biotech industry with a broad understanding of regulatory requirements across the product development lifecycle.

TOPICS TO BE DISCUSSED:

• The Evolution of Drug Compliance in the US
• FDA Structure and Function
• The Product Development Timeline from IND to Commercialization
• Good Laboratory Practice
• Good Manufacturing Practice
• Compliance across the Product Development Lifecycle
• The CMC Section of the Initial IND
• Meetings with FDA during Drug Development
• The BLA, NDA and Beyond

INSTRUCTOR BIOGRAPHY:

Christine Vessely, PhD, Senior Consultant, Biologics Consulting Group

Christina Vessely, PhD, RAC, has over 18 years of experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research and development for small and start-up firms through late stage development and commercialization for mid-sized and large pharmaceutical companies. She has been involved in priority review and fast track programs, she has participated in pre-approval inspections (PAI) and PAI enabling activities such as design and execution of validation studies and evaluation of GMP systems, as well as the authoring and editing of analytical sections for multiple filings in both the U.S. and in the EU (IND/IMPD, BLA/MAA).

Training Seminar Information

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the Training Seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.