Module 12 2019

Business cases

Business cases that were developed by Regulatory Optimisation Group (ROG): 1. Optimising Variations Process 2. Pharmacovigilance (PSUR/ICSR) 3. Falsified Medicines Directive

4. Use of SPOR: Article 57 Database replacement 5. Other optimisation ideas: CTS read access, etc

Research

Development

Lifecycle Management

Registration

Approve Candidate Molecule

New Country

Phase 3 Trials

Scientific Advice

Phase 1 Trials

Paediatric Program

Decision to Submit

Phase 4 Studies/IIS

Safety Reporting

MAH Transfer

Launch

Approval

Review

3

4

1 2

Submission MAA/NDA

Start research program for target Candidate ready for development

Phase 2 Trials

Patient Support Program

HTA Post Marketing Surveillance

Additional Indication

Variations

Renewal

Withdrawal/ Suspension

The Organisation for Professionals in Regulatory Affairs