Overview
The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance.
Information regarding chemistry, manufacturing and controls (CMC) for drugs is an important and detailed section in the dossier to support clinical studies and marketing applications. This data must be updated as more information is gained throughout a drug’s lifecycle.
The quality module of the Common Technical Document (CTD) presents the CMC data in the submission dossier for small and large molecules. Compiling the CMC regulatory material is challenging; however this needs to be completed with efficiency and accuracy to gain fast approval.
This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.
This is a key opportunity to learn from an expert in the field of CMC requirements and compliance, and discuss the complexities involved.
Please note, it is recommended that attendees have some experience with Module 3 of the CTD.
CPD Hours: 12
Course Content
- Day 1
- Understanding Biologics
- CMC Regulatory Guidelines for Biological Drug Products - Part 1
- CMC Regulatory Guidelines for Biological Drug Products - Part 2 (continued)
- Understanding the Key CMC Aspects of the Common Technical Document (CTD) - Part 1
- Understanding the Key CMC Aspects of the CTD - Part 2 (continued)
- CMC Regulatory Requirements During Differenct Stages of Development - Part 1
- CMC Regulatory Requirements During Different Stages of Development - Part 2 (continued)
- Day 2
- CMC Regulatory Requirements During Different Stages of Development - Part 3 (continued)
- Building the Pharmacuetical Sections of the Dossier
- Understanding Source Documents
- Change Control for Biological Products
Speakers
Andrew Willis
Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.
He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.
