Module 1 2021

25/06/2021

Shaping regulatory guidance development (EU example) - Consultations

The EU regulatory network (EC, EMA, CMD(h), etc…) regularly publish new documents for consultation:

• Reflection papers • Concept papers • Draft guidance • Update to legislations

The Organisation for Professionals in Regulatory Affairs

17

Influencing regulatory guidance development (EU example) - Commenting

Identify Expert(s)

Kick-off meeting

Collect responses

Consolidate responses

Submit

• Use expert network • Can be challenging

• Summarise document • Provide guidance • Timelines • Responsibilities

• Reminders

• Align messages • Propose alternatives • Formatting

• Submit on-time

The Organisation for Professionals in Regulatory Affairs

18

9