Dr. Fatima Bennai-Sanfourche is working currently as Senior Director of QA & RA Compliance for Medical Devices, Combinations Products, and eHealth at Bayer AG.

Previously she worked in the medical affairs and pharmacovigilance department at Bayer as director of medical device safety global pharmacovigilance/medical device safety officer.

She has more than 15 years of experience in the quality management and regulatory affairs of medical devices field, and over 20 years of supervisory and leadership experience including hiring, training, and performance evaluation.

She studied biology with a focus on biochemistry, immunology, and pharmacology, and did her PhD in pharmacology and pharmacochemistry in Strasbourg, France. She started her professional life with more university-oriented areas doing research and development in France, Sweden, and Germany with a focus on cerebrovascular diseases, such as stroke, regulation of hypertension, and development of immunoassays.

In her current position at Bayer AG, her focus is ensuring the regulatory compliance as well as high product quality of medical device, combination products, and eHealth components of the pharmaceuticals portfolio.

She is also responsible for ensuring compliant use of medical devices and medical software tools in the context of clinical investigations and clinical trials, including accordance with medical device good clinical practice (GCP). She is also leading the project of the implementation of EU MDR for PH-Bayer AG.

She was nominated in 2019 by the European Commission as EFPIA observer for the post-market surveillance and vigilance subgroup (GROW.D4) responsible for the implementation of these process according to the medical device regulation. The period of nomination is of five years starting on March 1, 2019.

Wendy Woodley is a Staff Scientist II for the Translational and Clinical Sciences Center of Excellence at BD Technologies and Innovation (BDTI). She is a published author and inventor with 21 years of R&D and product development experience in the medical device industry with a focus on innovation in drug delivery devices and diagnostics. She received multiple degrees (BS microbiology, BS zoology, BA English, BA history) from North Carolina State University. Her current work at BDTI focuses on drug delivery innovations with a concentration in preclinical model development, clinical testing, and translation of new ideas to product development.

A thought leader in Medical Devices and Combination products in the EU & RoW, Juan leads Global Pharma clients in complex compliance projects to meet the latest regulatory requirements. In his role as Managing Director at Beyond Conception, Juan has pioneered efforts in Combination Products in Europe by leading clients to obtain Notified Body Opinions as well as achieving compliance with the EU MDR and EU IVDR and other global regulations. His insights of the EU framework on medical devices and combination products and experience in Notified Body interactions and submissions have made Juan a constant speaker at leading conferences. His focus is on creating value beyond compliance and understanding thoroughly business needs to the deliver the highest value to his clients.

Min is a Senior Director at AstraZeneca and leads the pre-filled syringe technology development for the company’s biologic pipeline. He has over 15 years of pharmaceutical product development experience. Prior to AstraZeneca, Min was the drug product lead at Johnson & Johnson. He has worked on projects from discovery phase through commercialisation. His experience spans formulation development, process engineering, and manufacturing. Currently, Min is focusing on development for new therapeutic technologies, including digital health and cell and gene therapy. Min received his PhD in materials science and his MBA from US. Min is an inventor or author of more than 100 issued patents and patent applications and peer-reviewed publications.

Jean-Sébastien Steffen leads the combination product and primary packaging development organization with Lonza Drug Product Services (Basel, Switzerland).  He supports Lonza’s customers with 14 years of experience in medical devices and combination products development. He notably contributed to the success of 18 marketed drug-devices combination products.

Jean-Sébastien has also been a key player in establishing global pre-filled syringe technology platforms for different large pharmaceutical companies and has developed extensive expertise regarding container closure integrity, drug-container interaction, and combination product functionality. As a certified lean six-sigma black belt since 2016, he particularly enjoys implementing innovative scientific discoveries in efficiently running processes.

Jean-Sébastien holds a PhD in health engineering from Arts et Metiers ParisTech (France) and a master’s degree in mechanical engineeering from Karlsruhe Institute of Technology (Germany).