•  EN 
  • Employee login

Program Training School 2

Print 

​​​​Theme: Regulatory aspects of personalized medicine: the basics
Topic: Current personalized drug registration experiences
Learning objectives: To get an understanding of the basics of medicines regulation. In addition, challenges to drug evaluation with more personalised medicine approaches will be introduced.​

​​Date​​​

Time

Program/event​

June 17, 2019

9.00 - 10.30

Drug Approval. What Regulatory Tools
An EU and global perspective​

10.30 - 11.00

​​​​​​Break

11.00 - 11.45

Pre-clinical assessment

11.45 - 12.30

Clinical Assessment. SGLT-2 inhibitor
A non-personalised approach!?

12.30 - 13.30

Lunch

13.30 - 14.15

Clinical Assessment. PDL1/checkpoint inhibitor
A personalised medicine drug approval!

14.15 - 15.45

Structured Benefit / Risk assessment

15.45 - 16.15

Break

16.15 - 17.15

Pharmacovigilance & Risk Management Plan

17.15 - 17.30

Questions, Tomorrow & Closure

June 18, 2019

9.00 - 17.30

Based on published studies (PD, dose-finding and pivotal outcome study) students will have to write a Benefit-Risk Assessment using the structured B/R section of the CHMP report Clinical Overview and provide an outline for a suitable Risk Management Plan

June 19, 20​19

10.15 - 10.45

The use of Patient-Reported Outcomes in regulatory decisionmaking. Development, validation and Context of use

10.45 - 11.15

How and where are patients involved in the EU regulatory system

11.15 - 11.30

Break

11.30 - 12.15

Subgroups. Methodological considerations

12.15 - 12.45

Subgroups. Gender

12.45 - 13.30

Lunch

13.30 - 15.30

Board Meeting
- discussion of four case studies in front of ‘CBG Board Members’
- 30 minutes (incl. 5 minute presentation) per case
CBG assessors will scrutinise PROMINENT PhD reports

15.30 - 16.00

Break

16.00 - 16.45

Regulator meets Scientist
How to bring a medicine to the market?
One-on-one discussion followed by plenary questions

16.45 - 17.15

Closure (Regulators and Personalised Medicine)

June 26, 2019

9.00 - 12.00

PROMINENT-specific workshop by the Central Medical Library (Pubmed, search strategy, Endnote)

 

 

 

Sept/Oct 2019

 

Publishing in English

Sept 25, 2019

9.00 - 12.00

PROMINENT-specific workshop by the Central Medical Library (visibility and impact)

Oct 2019

 

Presentation Skills​​​​