In this webinar experts from the Recipharm team will discuss the challenges drug companies face in keeping up with a fast-changing regulatory landscape when developing APIs from R&D to commercial, both for New Chemical Entities (NCEs) and APIs for the generic market.
As guidelines from authorities become ever more stringent, the Chemistry Manufacturing and Controls (CMC) has to be continuously updated for lifecycle management of products. Even if the API is already on the market, new registration for other countries or new finished dosage forms has to be compliant with any new guideline adopted by regulatory authorities, whether regarding impurities, starting material definition, or analytical methods. The patent scenario also has to be considered for a full compliance during development.
Working with a Quality by Design (QbD) mindset in these cases leads to faster development and shorter time-to-market when seeking approval from regulatory authorities on new registrations.
In the webinar, the experts will focus on the following topics:
- The changing regulatory environment for today’s Drug Master Files (DMFs).
- Review updated ICH guidelines.
- Manufacturing considerations for today’s drug substances.
- CMC documentation requirements.
- Importance of lifecycle management and regulatory intelligence.
- Common issues in today’s market related to regulatory compliance.
Attendees will also hear a case study, demonstrating how, with Recipharm’s expert support, a drug developer was able to overcome challenges in harnessing an established API and developing it into a new finished dosage form. They will learn how Recipharm worked with the customer to address the issue of the API’s outdated DMF, updating documentation to meet more new regulatory requirements. They will hear how collaboration between different Recipharm facilities supported the customer in streamlining all stages of the development process, from manufacturing to regulatory compliance, to impurity identification and support to formulation experiments, as well as generating new intellectual property (IP) to deliver an effective new product.
Key Learning Objectives
- Understand the challenges posed by the current regulatory environment
- Learn how to address challenges in lifecycle management when developing and maintaining a drug substance
- Learn the benefits of collaboration with an experienced CDMO with an integrated service offering to reduce risks and timelines
