Programme 29 September 2020
09.00 – 09.15 h Introduction
09.15 – 10.00 h
The European Active Substance Master File
- Procedure – An Introduction
- Regulatory background and Scope
- The revised ASMF guideline
- Open and closed parts – points to consider
- Comparison of ASMF and CEP procedure
10.00 – 10.15 h
Q & A Session
10.15 – 10.45 h Break
10.45 – 11.30 h
Drug Master File Procedures in the US
- Types of Drug Master Files
- Drug Master Files under GDUFA
- Submissions of DMFs
- Holder obligations
- Maintenance of Drug Master Files
- US vs EU DMF – differences in the procedure
11.30 – 11.45 h
Q & A Session
11.45 – 12.30 h
Handling Changes in the EU
- Why is there a need for changes
- Types of changes
- How to communicate with the MA holders and how to get feed back
- Differences between ASMF and CEP
- When to implement a specific change
- Version management of the ASMF
12.30 – 12.45 h
Q & A Session
12.45 – 14.00 h Break
14.00 – 14.45 h
Post Approval Changes in the US
- Post approval activities
- Reporting requirements to the FDA (CBE 0, CBE 30, Annual Report)
- Post approval commitments and post approval reporting requirements
- Risk evaluation and mitigation strategies (REMS)
14.45 – 15.00 h
Q & A Session
15.00 – 15.30 h Break
15.30 – 16.30 h
Description of the Active Substance Manufacturing Process
- Regulatory basis - relevant guidelines
- Description of the Active Substance Manufacturing process
- Active substance starting material
- Critical steps in the synthesis
- Process validation
16.30 – 16.45 h
Q & A Session
Programme 30 September 2020
08.30 – 09.15 h
Comparison of the CEP and ASMF Procedure
- The certification scheme of the Ph.Eur.
- Advantages and disadvantages of the CEP procedure compared to the ASMF procedure
- Handling of variations in the CEP procedure
- Countries accepting CEPs
09.15 – 09.30 h
Q & A Session
09.30 – 10.15 h
How to document Drug Substance Stability
- Stability Guidelines
- Stability Testing of new drug substances and drug products
- Storage Conditions
- Bracketing and Matrixing Designs
- Stability data from new drug dosage forms
- How to document evaluation of stability data
- Optimising the submission
10.15 – 10.30 h
Q & A Session
10.30 – 11.00 h Break
11.00 – 11.45 h
Residual Solvents and Impurities: Synthesis derived Impurities, Metals and genotoxic Impurities
- Guidelines
- Impact of the new guidelines ICH Q3D and ICH M7
- Sources of Impurities
- Setting and justification of specifications
- Residual solvents, solvent classes
- Content and scope of data – documentation requirements
- Frequent mistakes
11.45 – 12.00 h
Q & A Session
12.00 – 13.00 h Break
13.00 – 14.15 h
Requirements of the Drug Master File Procedure in Japan (Part 1 and 2)
- Regulatory procedures in Japan:
- Site accreditation
- GMP paper-based inspection
- Drug Master File
- Drug Master File format
- Specific points to consider for the J-DMF
- Communication with the Japanese authorities
14.15 – 14.30 h
Q & A Session
14.30 – 15.00 h Break
15.00 – 16.00 h
Workshop
Managing Changes in Drug Master Files – Case Studies
16.00 – 16.30 h
Final Q & A Session