1. Women’s Health Technologies CRN
Annual meeting: 7th Sept 2018
Women’s Health Technologies CRN
Dr. Alex Asiimwe
Epidemiology Head Therapeutic Area
Womens Healthcare (WHC)
BAYER AG
/// Bayer 16:9 Template /// December 2017

2. LARC/Sterilization products

3. How can CRN be helpful? Conduct epidemiological Studies
Better understand the users of LARCs
Switchers and reasons
Duration of therapy
Indication of use
Safety or Efficacy studies
Regulatory /non regulatory responses
Surveillance or monitoring purposes
feed into MAH existing postmarket surveillance systems
Support phase IV studies or RCTs
Label changes
Extensions
New indications
Collaboration:
Regulators,
Patients, Manufacturers,
HCPs

4. Expectation going forward?
Clear FDA’s guidance with regard to application for real world data- more dialogue despite consensus guidance???
Clarify expectations of industry ’s role/scope/level of commitment
industry’s role in improving the quality of data in the registry
industry representatives on CRN bodies such as core team, clinical area team, and the multi-stakeholder advisory group.
Transparency on how will this initiative be funded?
What could be the process?
Sustainability plan?
Documentation on collection and processing of key data parameters
Clear strategy on enrollment

5. Expectation going forward?
Will the industry be able to exploit CRN?
Processes, guidance and when
Process on research operational structure of CRN
Journey from research question to study report and dissemination of results
Transparency on protocol development
Opportunity for industry/patients/professionals comment on protocols
Continue dialogue with FDA’s/CRN leadership:
What is expected from the industry?

6. Thank you for your attention!
/// Overview Pharmaceuticals Division of Bayer /// April 2018