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

LARC/Sterilization products

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

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

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?

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