Current position and relevant professional experience:
Janine is currently European Editor for International Pharmaceutical Quality Journal (IPQ) on emerging regulatory challenges, including drug-device combination products, advanced therapy products and innovative manufacturing technologies. IPQ is headquartered in Washington D.C., with strong connections to FDA.
Previously, Janine was a pharmaceutical assessor in the Licensing Division of MHRA, working with medical device colleagues and notified bodies on borderline and drug-device combination (DDC) products. She contributed to the MHRA Innovation Office and Horizon Scanning activities, EU Innovation Office network, development of MHRA guidance and cross-Agency working group on DDCs and MHRA position on the new medical device regulations.
Following a move to Sweden, Janine became a freelance consultant working with small medical device companies utilizing medicinal substances, at the same time contributing to pharmaceutical industry reflection papers on regulation of DDCs.
Current or previous involvement in TOPRA activities:
- Proposed and co-chaired TOPRA/RAPS Inter-regulatory and Stakeholder Workshop Addressing the Impact of the EU Medical Device Regulation on ‘Combination Products’ November 2018, Brussels
- Chair of TOPRA Medical Device Symposium 2018, Stockholm
- Chair of joint Human Medicines/Medical Devices sessions at TOPRA Symposia 2016–2019
- Chaired Working Party for new TOPRA CRED Course on DDCs 2017 and 2019
- TOPRA MedTech SPIN Steering Group member since 2014
- Author/contributor to several articles on borderline and combination products for Regulatory Rapporteur, including interview with John Weiner from FDA Office of Combination Products
- Contributed to Regulatory Intelligence SPIN review of RI resource booklet
- Submitted nominations for TOPRA Awards for Communication and Contribution
- Currently contributing to Professional Development Strategy Focus Group
Personal statement:
If elected, it would be a privilege to further contribute, based on my experience from:
- Academia (PhD and post-doc in drug delivery)
- Regulatory agency (MHRA: 18 years working with medicines and medical devices)
- Medical devices industry (small MD companies and MedTech SPIN steering group)
- Medicinal products industry (co-authoring EBE/EFPIA reflection papers on regulation of combination products; attending key international conferences on quality issues for current and emerging medicinal products and technologies)
I have a passion and enthusiasm to bring people from different backgrounds together - for sharing experiences, understanding different perspectives and collaborative working towards appropriate, risk-based and pragmatic regulatory solutions.
Nomination information
Proposer: Tim Chesworth; Sponsors: Robin Stephens, Stephen Hayes