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 that 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 that it is recommended that attendees have some experience with Module 3 of the CTD.
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
Course Provider
Mr Andrew Willis,
Consultant ,
IndependentAndrew 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. Catalent is the world’s leading contract manufacturer and distributor of pharmaceuticals, and 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 has 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 currently has a total of 28 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. Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.
Who Should Attend
- Regulatory, Quality Assurance and Manufacturing personnel
- Managers of a CMC area
- CMC Project Managers
- Quality Assurance Managers for Biological Products
- Individuals who are new to drug companies
