Module 1 2021

Module 1: Strategic Planning in Regulatory Affairs 30 th June - 2 July 2021

Date : Thursday 1 st July 2021

Chairperson Ineke Jonker-Hoogerkamp

Time (BST)

Activity

Speaker

09.30 - 10.30

Lecture 6: Orphan Drugs – Strategic Considerations Regulatory Strategy in orphan drug development – keep your stakeholders aligned

Liesbeth Hof ProPharma Group

10.30 – 11.00

Refreshment Break

Lecture 7: Electronic Submissions (eCTD) – Strategic Implications Gateways, Electronic data standards, Impact for global roll-out, Implications for smaller companies ; PIM

11.00 - 12.00

Matthew Pazdernik Organon

12.00 – 13.00

Lunch

Module Leader

14.00 – 16.30

Case Study – Global Project Development Strategy with Refreshment Break