Information- and Data Exchange in Regulatory Affairs

• History of Regulatory Submission
• Emerging Trends
• Dynamic Submission Management
• Solutions and Characteristics

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

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

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

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

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

Part 1
Friday	23.02.2024 von 08:30 - 18:00 Uhr	Online
Saturday	24.02.2024 von 08:30 - 18:00 Uhr	Online

Part 2
Friday	01.03.2024 von 08:30 - 18:30 Uhr
Saturday	02.03.2024 von 08:30 - 14:00 Uhr
Submission of study paper	Sunday, 26.05.2024