Agenda

Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.

Featured Sessions

 

Unpacking Recent ICH Guidelines
Oct 15, 2024 | 1530 - 1700
Presenters: Multiple
Join us at the Global Implementation Strategies Forum to engage with industry experts and regulators on the Global Adoption Status and Implementation Strategies for ICH Q2(R2)/Q14 and Q12 guidelines. Discover how these science- and risk-based approaches to lifecycle management are ensuring the continued quality of drug substances and drug products worldwide. Explore how ICH Q12 provides tools for effective post-approval change management and regulatory reporting, while ICH Q2(R2)/Q14 focuses on the development, validation, and lifecycle of analytical procedures. 
ISPE Regulatory
Town Hall
Oct 16, 2024 | 0950 - 1120
Presenters: Multiple
Join us at the Regulatory Town Hall where you can engage with International Regulators and Industry thought leaders on topics including progress on Mutual Reliance, new methodologies on information sharing between industry and regulators, new product development paradigms, the use of mechanistic models to support physiologically based pharmacokinetics useful in product development and evaluations of medicines and vaccines. 

All session times are listed in Eastern Time (ET). Find your personal viewing time on the World Clock.

Speakers

Selected filters:

  • Maotang Zhou
Tue, 15 Oct
1115 – 1145

Regulatory Considerations on Complex APIs Sameness

Regulatory - Compliance - Quality
Maotang Zhou, FDA
As part of the abbreviated new drug application (ANDA) evaluation, FDA recommends applicants fully understand the potential for changes in or to the active ingredient during the manufacturing process. Complex APIs are often mixtures of different components and can contain a distribution of molecular weight.  Due to their complexity in both composition and structure, complex APIs cannot be characterized by typical analytical techniques.  To demonstrate the sameness of a complex API in a generic drug product, a “totality-of-the-evidence” approach is generally employed during regulatory assessment.  This approach includes three key components: manufacturing process understanding, orthogonal characterization, and comparative biological activity analysis, if necessary.  Unlike well-defined small molecule APIs, manufacturing processes are especially critical in ensuring the consistency of composition and properties for complex APIs.  This presentation will provide an overview of key regulatory considerations on demonstrating complex API sameness.  Additionally, we will present regulatory resources that are available to facilitate the development of complex generic drug products containing complex APIs.
Maotang Zhou
Division Director
FDA

Hear From Top Industry Thought Leaders and Regulators on the Challenges and Solutions Impacting the Pharmaceutical Industry

Speaker Qualifications

Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.

Agenda Changes

Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.