| Information- and Data Exchange in Regulatory Affairs |
- History of Regulatory Submission
- Emerging Trends
- Dynamic Submission Management
- Solutions and Characteristics
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| Regulated Information Systems - Agency Perspective |
- Value of Electronic Information Systems
- IDMP and SPOR
- Pharmacovigilance Systems
- Clinical Trials
|
| Information Systems of the BfArM |
- Information Systems and their legal basis
- PharmNet.Bund Portal - Purpose and User Groups
- PharmNet.Bund Portal Use Cases
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| Document-Management for Regulatory Affairs |
- Paper vs. Electronic Documentation
- Use Cases in Regulatory Affairs
- Implementation of a DMS System
- Organization, Training, Standardization
- Vendor solution examples
- Selection criteria and purpose of use
|
| Artificial Intelligence in Drug Regulatory Affairs |
- History and Status
- Ein Use Cases in Regulatory Affairs
- Different concepts and methods
- AI and Big Data – Data Mining
- Business Process Automation
- Europa und AI-Projects, ChatGPT
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| Planning and Management of Projects in Regulatory Affairs |
- Project and Data Management
- Managing Regulatory Information
- DRA Lifecycle Management
- Important projects and respective data in Regulatory Affairs
- Analysis of Data and Reporting
- Project Management
|
| Management of Documentation |
- Documents and Documentation
- Medical Writing
- Standard Operating Procedures
- Implementation of a Content Management-System
- (Goals, Process, Teams, Schedules)
|
| Electronic Submission at Agencies |
- Process of Electronic Submission at the BfArM
- EU Electronic Application Forms
- Common European Submission Platform (CESP)
- Online Regulations and relevant Laws
- National Procedures
|
| Scientific Databases |
- Introduction in Search and Research of Literature
- What are the basics of relevant Databases?
- Process and use cases (e.g. PubMed)
- Requirements in Regulatory Affairs
|
| Process of eCTD Compilation and Publishing |
- Documents and preparation
- eCTD Table of Content
- Step by Step Process of building an Electronic Submission
- Publishing to Global Agency Portals
- Review Process at Agencies
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| Process of eCTD Intake and Review at an Agency |
- eCTD Processing for EU-Regulators (CESP)
- eCTD for different use cases (Common Repository and PSUR)
- Technical Validation
- Process of Assessments
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| Management Data for Electronic Application - Industry Perspective |
- xEVMPD/IDMP/SPOR
- PharmacoVigilance Legislation
- EudraVigilance Database Management
- The xEVMPD/SPOR Mandate Art57 Database
- CTIS Clinical Trial Database
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