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 They will learn how Recipharm worked with the customer to address the issue of the API’s outdated DMF, updating documentation to meet more new regulatory requirements.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.
Presented by
Aaron Small,
Vice President Global Development Sales
Aaron Small is Vice President Global Development Sales at Recipharm. He holds a BSBA degree in Marketing and a MBA and has been a part of Recipharm since 2011. During his time in Recipharm, he has contributed to business development activities for both development and manufacturing services. In addition, Aaron has been a part of brand development and deployment for the North American market.
Wendy Whitfield,
Head of Regulatory Affairs
Wendy Whitfield is Head of Regulatory Affairs at Recipharm. With a BSc Hons in Chemical and Pharmaceutical Sciences and a PhD Medicinal Chemistry, Wendy brings a wealth of knowledge to the team, as well as over 20 years’ experience in the pharmaceutical industry. She has held several previous roles, including QC Analyst, Product Quality Review Co-Ordinator, Development/Process Chemist, Project Manager, QA Officer, Regulatory Affairs.
Matteo Zacché,
R&D Manager
Matteo Zacché is R&D Manager at Recipharm. Having completed his MSc studies at the University of Milano in 2001, he began working in the pharmaceutical industry. Over the last 15 years, Matteo has worked with his team to develop several new APIs, including NCEs and generic APIs, resulting in the filing of 12 process patents for the company. Having begun as a junior researcher, Matteo progressed to a senior researcher role in scouting and optimisation of API manufacturing processes, to his current role as R&D manager at Recipharm’s Paderno Dugnano plant in 2006.
