Dublin, Sept. 29, 2023 (GLOBE NEWSWIRE) -- The "Development of Combination Products: Critical Interactions Training Course" conference has been added to ResearchAndMarkets.com's offering.
This program provides valuable insights into crafting an effective regulatory strategy while addressing crucial aspects of Good Manufacturing Practices (GMP) and quality processes. It also sheds light on the data expectations essential for the Common Technical Document (CTD).
In today's medical industry landscape, drug/device and device/drug combination products are gaining prominence. However, their development and manufacturing pose intricate challenges, particularly in terms of quality and regulatory compliance.
Our interactive seminar serves as a guide to understanding both the European Union (EU) and US approaches to handling drug/device and device/drug combination products. We will delve into the prerequisites for the device technical file/design file, elucidate the regulations governing biological and synthetic drugs, and demystify the registration procedures for these innovative products.
Furthermore, this seminar will emphasize the interconnectedness of quality, regulatory affairs, research and development (R&D), and production functions. Delegates will benefit from a comprehensive overview of the specific requirements associated with these products and gain the opportunity to engage in insightful discussions with a subject matter expert. Join us to navigate the complexities of this dynamic field successfully.
Benefits of attending:
- Clarify the definitions for drug/device and device/drug combination products in the EU and USA
- Consider the requirements for the device technical file/design file
- Comply with the biological and synthetic drug regulations
- Understand the registration procedures for devices and medicines in the EU and USA
- Determine the data required for the Common Technical Document (CTD)
- Consider the regulatory strategy depending on your product
- Gain practical advice on how to apply the ISO standards
Who Should Attend:
- All development, regulatory and quality personnel involved in the development of combination products (drug/device and device/drug products)
- Pharmacovigilance/vigilance personnel
- Device experts looking to expand their knowledge to medicines and vice-versa
Agenda
Defining a drug/device and device/drug product
- EU approach
- US approach
Regulatory procedures for drug/device and device/drug products
- EU procedures
- US and Office of Combination Products
Understanding devices
- Medical Device Regulation - EU
- CE marking and Notified Body interactions
- CDRH definitions - US - 510(k) and PMA
- Labelling
- Vigilance requirements
Device technical file/design file
- What is required
- Structure
- Bench testing
- Potential clinical requirements
Workshop: Technical file/design file
Understanding the biological and synthetic drug regulations
- EU/US definition of medicinal product
- Labelling
- Pharmacovigilance
- Quality requirements
Registration procedures
- EU approach
- US approach
GMP and ISO standards
- Practical application
- Interpretation of the standards
The CTD
- Where to put data
- Data expectations
- Applying QbD (quality by design)
Workshop: CTD requirements - tracking critical documents
Key considerations for the regulatory strategy
- Deciding which regulatory route to take
- Device and product registrations
- Combination-only registrations
- Desired labelling
Workshop: regulatory strategy
Speaker
Andrew Willis
Consultant
Independent
Andrew Willis is a seasoned independent consultant with a wealth of expertise in global regulatory solutions and pharmaceutical development. He previously held the position of VP Regulatory Affairs & Consulting Services at Catalent Pharma Solutions, a world-renowned pharmaceutical contract manufacturer and distributor.
With a solid background of 10 years in manufacturing and analytical roles, he transitioned into regulatory affairs as a Senior Executive Officer. In this capacity, he oversaw the submission of European Marketing Authorization Applications (MAAs) and project management for development initiatives.
With a remarkable career spanning 28 years in the pharmaceutical industry, Andrew possesses extensive knowledge across various domains, including the development and manufacturing of sterile, solid oral, inhalation, topical, and biotech pharmaceutical products.
His diverse experiences encompass the requirements of Biotech products, notably in growth hormones and multiple cancer treatments. Of note, Andrew played a pivotal role in the development and clinical registration of the first genetically modified live bacterium for cancer treatment.
Furthermore, Andrew boasts a wealth of experience in managing major European and US regulatory projects, encompassing both clinical and marketing authorization phases.
For more information about this conference visit https://www.researchandmarkets.com/r/a7ze70
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
