1 Introduction to clinical trials and clinical medicines development

• Identification of an unmet medical need
• Medicines Development Process 
• Definition of Clinical Trial 
• Structure of a Clinical Trial 
• Types of and Designs of Clinical Trials 
• Phases of Clinical Medicines Development 
• Adaptive Pathways 

2 Ethics in clinical research

• Declaration of Helsinki
• Ethical principles
• Ethical review process for clinical trials
• Ethical conditions for clinical trials and informed consent in vulnerable populations
• GCP requirements for ethics committees

3 Good Clinical Practice (ICH-GCP(R3))

• Structure and content overview 
• GCP principles 
• GCP requirements for investigators and sponsors
• Quality by design
• Risk-adaptation and management

4 Essential documents and filing in clinical trials

• Definition and filing requirements for essential documents in clinical trials according to ICH-GCP(R3) 
• Familiarisation with the content of core documents in clinical trials

5 Quality management in clinical trials

• Quality management in clinical trials 
• Monitoring – auditing – inspections

6 Scientific questions in the label to be answered in Phases 1,2, and 3

• Phase 1: Clinical pharmacology (PK, PD, pharmacogenetics)
• Phase 2: From proof-of concept to dose-response relationship
• Phase 3: Confirmatory clinical trial designs, statistical and organisational challenges

7 Investigational medicinal products

• Manufacturing and import
• Labelling
• Responsibilities of the Qualified Person
• Reconstitution
• Drug accountability

8 Clinical development strategies

• From TPP to clinical development plan
• Current paradigm shifts in drug development
• The most important mistakes in clinical development strategy
• Impact of Covid on regulatory science
• New developments in regulatory sciences

9 Paediatric clinical development

• Drug development considerations for paediatrics
• Important international requirements for paediatric clinical studies
• Case study

10 Biostatistics in clinical research

• Introduction and trial designs
• Statistical tests
• Multiplicity
• Sample size
• Estimands
• Data management

11 Safety in clinical trials

• Clinical safety guidelines
• Definitions
• Reporting obligations and Eudravigilance database
• Reference Safety Information

12 Postmarketing clinical studies

• Definition and description of different types of studies in Phase 4
• Legal requirements in Germany for different types of Phase 4 studies
• Phase 4 clinical studies and Good Pharmacovigilance Practices

13 The clinical trial protocol

• Preparation and review by the sponsor
• Review and assessment by the competent authority
• Review and assessment by the ethics committee incl. EU Dossier Part II documentation

14 Translation of clinical trials into labelling

• SmPC
• Package leaflet and package labelling
• EPAR
• Exercise on translating clinical trial results into labelling

15 The regulatory framework for clinical trials

• Why and what needs to be regulated in a clinical trial?
• Essentials of the CTR
• The single dossier
• Coordinated assessment procedure for trial authorisation and substantial modifications
• CTIS Submissions (Initial, Modifications, MS) 
• Transparency and Data Protection
• Legal conditions for clinical trials in Germany
• Regulatory frameworks for other studies

16 International clinical trial authorisation systems

• Europe
• USA
• Japan
• India
• China
• Australia
• South America

17 Reporting obligations in CTIS

• Transparency requirements
• Protection of personal data and commercially confidential information
• Transparency rules in CTIS and public portal
• Reporting trial results
• Notifications in CTIS

18 Reconstructing a competitor’s clinical trial from information accessible in CTIS

• Introduction to CTIS
• Navigation through CTIS
• Application and Information
• Exercise on reconstructing sponsor and trial information 

19 Crash course

• The regulatory affairs expert’s role in clinical development and clinical trials
• Joint repetition of key aspects, definitions, rules, responsibilities, processes, sponsor obligations and development strategies in clinical development and clinical trials 

Part 1
Friday	26.06.2026 von 08:30 - 14:45 Uhr	Online
Saturday	27.06.2026 von 08:00 - 16:15 Uhr	Online

Part 2
Friday	10.07.2026 von 08:30 - 15:45 Uhr	Online
Saturday	11.07.2026 von 08:00 - 15:00 Uhr	Online