Sprecher
Dr Rainer Gnibl, EU-GMP Inspector, Bavarian Government, Germany
Dr Josef Hofer,EXDRA GmbH, Germany
Dr Usfeya A Muazzam, Bonn, Germany
Zielsetzung
- the basic requirements for drug approval in Europe, the US and Japan
- the structure of the marketing authorisation dossier according to the CTD
- the input from the GMP regulated departments
- drug approval procedures in the EU and US
- documents to be provided and timelines to be observed
- how to handle changes and variations in the EU, the US and Japan
Hintergrund
For the maintenance of a marketing authorisation it is very important to know how to handle all the changes and variations occurring during the life cycle of a medicinal product. The rules for handling variations in Europe are laid down in the variations regulation (EC) No. 1234/2008 – being applicable as well for national marketing authorisations from August 3rd 2013 – and supporting guidelines. For handling changes in the US rules are provided in different guidances for industry and for approval of changes in Japan there are specific procedures in place to be followed. Maintaining marketing authorisations in a global scenario is a challenge and requires strategic planning and a good knowledge of the different regulations and timelines. Efficient and smooth communication between GMP and Regulatory Affairs is a key factor of success.
Zielgruppe
Technical Requirements
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Programm
What is a regulatory Dossier?
- Why do we need regulatory dossiers?
- Why are regulatory dossiers binding?
- Centralized procedure / Decentralized procedure
- Mutual Recognition
- National Procedures
- Specific Dossier Requirements for different Medicinal Products
- Time Lines
- Generic Applications
- New Drug Application (NDA)
- IND procedure and special issues
- Abbreviated New Drug Application (ANDA) – Generics
- Pre-approval inspections
- Timelines and meetings with the FDA
- Regulatory Requirements in Japan
- GMP Regulations in Japan (J-GMP)
- Quality related aspects of the SmPC
- Clinical particulars
- Pharmacological properties
- Pharmaceutical particulars
- Labelling
- Package Leaflet
- Mock ups and Specimen
- Quality Experts, Non Clinical and Clinical Experts
- Bibliographical applications
- Homeopathic Applications
- Pediatric Applications
- Regulatory background of QOS
- Benefits (and why you can call it „Queen of Submission“)
- Frequent deficiencies, examples
- Optimising the submission
- Medicinal product – documentation of quality in Module 3
- Impurities
- Stability data
- Container and closure systems
- Critical parameters
- Optimising the submission
- Risk based approach in industry and regulatory authority
- Documentation of drug substance quality in Module 2
- The Quality Overall Summary (QOS)
- CEP and ASMF procedure – how they work in principle
- Types and format of ASMFs
- Contents of the applicants part and the restricted part
- How to apply for a CEP
- Dossier Content
- CEP assessment and CEP inspections
- DMF procedures in US and Japan
- Clinical study reports
- Efficacy and safety
- Clinical summary and clinical overview
- Non clinical study reports
- Toxicology
- Pharmacokinetics
- Safety studies – decision tree
- Toxicity studies to qualify impurities
- Non clinical summary
- Critical points
- Types of inspections
- Essential PQS interfaces
- Change control from a GMP view
- Deviations from Marketing Authorisations
- Inspector’s planning, preparation, conduction and follow-up of GMP inspections
- EU-GMP regulations
- Technical terms of EU-GMP guidelines
- Basic requirements for GMP inspections
Handling Changes in the ICH countries
- Starting a change in your company
- The variations procedure in Europe
- General provisions of the Commission Regulation (EC) No 1234/2008
- Supporting Guidelines
- Best Practice Guides and Explanatory Notes
- Classification of variations
- Procedural handling of variations; Grouping, Worksharing
- Handling Changes in the US: Changes to an approved NDA and ANDA
- Types of changes
- Change control procedure and reporting mechanisms
- Handling changes in Japan: Change procedures and communication with the Japanese authority
- Types of changes
- Notification of changes
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