Getting Drugs Approved – What you need to know from a GMP Perspective
What is a Regulatory Dossier? - Setting the Scene for the Training
- Reasons for filing regulatory dossiers
- GMP aspects in regulatory dossiers
- Compliance of the regulatory dossier
Drug Approvals in the ICH Countries: Prerequisites and Procedures
- 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)
CTD Module 1 – Summary of Product Characteristics and other National Requirements
- 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
CTD Module 3 – Quality of the Drug Product: Relevant GMP Documents
- 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
CTD Module 3 - How to document Drug Substance Quality around the World
- How to provide CMC Information
- What information is required in Module 3.2.S
- Differences in interpretation of the requirements
- Differences in format
- Procedures in the various regions: US, EU, Japan, Brazil, China
CTD Modules 4 and 5 – Non-clinical and clinical Documentation: GMP, GCP and GLP Aspects
- 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
Regulatory Compliance Aspects during Authority Inspections
- 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
Technical Terms of GMP Inspections – EU-GMP Requirements
- EU-GMP regulations
- Technical terms of EU-GMP guidelines
- Basic requirements for GMP inspections
Other GMP Basics with MA & Regulatory Affairs Relevance
- Required authorizations, registrations, certificates and how to get them
- How to certify/release a batch?
- Which audits are on duty?
Maintaining a Marketing Authorisation – The Interaction between GMP and Regulatory Affairs
Handling Variations and Changes
- Why do we need to file changes
- Handling changes within an API company
- Impact of a change: categorization of changes
- Change procedures around the world: EU (ASMF and CEP), US, Japan, Brazil, China