Gert is an expert in European regulations based on 15 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, head of notified body. He led the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level.

Regulatory Affairs Senior Officer at the European Medicines Agency. Joined the EMA in 2004. Responsible for providing regulatory intelligence and advice in relation to the development, evaluation and surveillance of medicinal products for the Centralised Procedure. Involved in particular with the implementation of the paediatric and pharmacovigilance legislation. Currently, amongst other projects, closely involved in the implementation of the MDR/IVDR within EMA as regard to the aspects on medical devices used in combination with medicinal products and on the repurposing pilot. Before joining the Agency, gained experience at the French Competent Authority, in the Mutual Recognition Procedures and in the Industry.

Tim joined AstraZeneca in 2007 to lead a team responsible for developing delivery devices for AZ’s new drug portfolio. This encompassed all dosage forms and had a significant focus on inhalation and injection devices. Tim’s current role is to lead the Medical Devices & Combination Products group within AstraZeneca Regulatory Affairs. The group is responsible for developing and implementing regulatory strategies and processes for both new and existing medical devices and combination products. This encompasses conventional pharmaceuticals, biologics and AZ’s activities in Digital Health. Tim is a leading member of a number of medical device & combination product industry groups and associations.

Amanda has 22 years industry experience working at Pfizer, UK. Her career started as an Analytical Chemist before moving into the Regulatory group. For the past 17 years Amanda’s focus has been providing strategic support to global development programs and lifecycle management for a range of medical device and combination products. Amanda is an active participant in industry associations, namely CPC and EFPIA focusing on drug-device combinations and has significantly contributed to many advocacy position papers from Industry on this topic. Amanda is a contributor to ISO/TC84 and worked on the recent ISO 20069 standard for assessment of changes to drug delivery systems as well as contributing to ISO 11608 revisions.

Thomas is the Senior Director of Regulatory Affairs for Devices at Novo Nordisk and is responsible for devices and combination products and has extensive experience with regulating medical devices. As a former Director of Medical Devices in the DKMA and an MDCG member, he has worked with the public sector, MedTech-Industry and Patient-organisations to secure patient safety. He has been elected Chair of the Competent Authorities for Medical Devices and has experience in national and international arenas. Thomas holds a master’s degree in political science from the University of Copenhagen. He has undertaken several courses and continuing education in project management and leadership and has several years of practical management experience.

Sophie Tabutin, PharmD, MSc is leading the Europe, MEA and LATAM regulatory affairs team at W. L. Gore & Associates since November 2018. Prior to this, I was with BSI Notified Body for 5.5 years. First, as a product reviewer, technical expert, project manager and QMS assessor, then as Notified Body Regulatory Lead for BSI 0086. I have been actively involved in the preparation work for MDR to allow BSI to reach the key milestones in BSI designation under the MDR and IVDR. She is a qualified QP and pharmacist with 12+ years of experience in drug formulation, investigational drugs, and clinical research.

Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East and SEE regions. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.

Anja Wiersma, is a medical biologist with a PhD in the NeuroPharmacological field. After working for 8 years at the pharma company Organon N.V., she started to work for a Notified Body (total 6.5 years).She is qualified for both the Medical Device Directive (MDD 93/42/EEC) and the In Vitro Diagnostic Device Directive (IVDD 98/79/EC). Since 2010 she is a RA/QA consultant at mi-CE consultancy for medical device and IVD manufacturers, and she remains a contractor for several notified bodies.

Sebastian is Regulatory Strategist at TÜV SÜD in Munich. Before joining the notified body, he spent eight years as Regulatory Intelligence and Policy expert in pharmaceutical industry at Merck KGaA, Darmstadt. He is Biomedical Scientist by training (M.Sc.) and holds a master’s degree in Drug Regulatory Affairs. His key interests are regulation of combination products as well as digital medical devices and Artificial Intelligence.

- >20 years experience as pharmaceutical and medical device regulator in the Dutch government, successively in Medicines Evaluation Board, Ministry of Health and CCMO (governmental organization for clinical investigations) - Lead for European Regulation in Philips (global medtech company), co-leading Philips’ EU MDR/IVDR Implementation Program - Currently Regulatory Strategy Principal in Notified Body TÜV SÜD - Chair of NB-MED (formal EU Commission’s working group of Notified Bodies and Vice-President of Team-NB (association of EU Notified Bodies) - Long track record in global professional organizations DIA and RAPS - Regular speaker and faculty member in educational conferences on regulatory topics - Holding PharmD of Leiden Univer

Dr Jonathan Sutch is a Principal Medicinal Specialist at the Notified Body BSI Group, working with medical devices containing medicinal substances and drug/device combinations. Jon trained as a Pharmacist at the London School of Pharmacy prior to completing a PhD in Pharmaceutical Sciences at Nottingham University. He has 15 years of experience in the pharmaceutical industry as a formulation scientist and manager before moving to BSI 5 years ago.

Peter Bischoff Everding is senior expert in the Medical Device unit in the European Commission‘s Directorate-General Health and Food Safety (DG SANTE). He is in charge of legal aspects related to the implementation of the EU regulatory framework for medical devices and in vitro diagnostics. Before that, he was working in the fields of EU consumer law, consumer product safety and free movement of goods. Peter is a lawyer by training and holds a PhD from Hamburg law school in competition law.

Ruth has over 40 years experience working in the European medical sector covering many functions including Regulatory Affairs and Clinical Trials across a broad portfolio of medical products.  She is the Director of Medical Devices, Combination Products and Digital Health Solutions, working for MSD, France.  Ruth is the EFPIA nominated representative to the European Commision's COMBINE clincial trials programme and the MDCG for New Technologies.

Michael Kühler is a seasoned leader with over 25 years of experience in the medical device and combination product industry. Currently a Regulatory Affairs Senior Expert at Bayer AG, he focuses on global regulatory strategies for medical devices and drug-device combination products, including Notified Body Opinions. He also leads an EFPIA working group on “Consistency of NBOp Assessments.” Previously, he directed R&D and Regulatory Affairs at Hemoteq AG and managed R&D teams at B. Braun Melsungen AG, contributing to innovative device development. Michael holds a PhD in Biomedical Engineering from the Technical University of Berlin.

Engineer (Dipl.-Ing) in Bioprocess technology and Biochemistry. Worked as a product specialist in immunohematological products and plasma products with Sanquin blood bank, Amsterdam. QA and RA manager at IVD firm in the Netherlands. Worked for over 6 years as audit team leader, dossier reviewer and project manager at KEMA Medical Notified Body. Acted as IVD product specialist and Principal Certification Manager at DEKRA Certification, Business Line Medical (6 years). After this, worked for 4 years as a regulatory consultant, Alex now has the position of Head of the Notified Body IVD at BSI.

Ola is a Regulatory leader with 12+ years of experience in global regulatory strategy and lifecycle management. Currently Platform and Portfolio Director at Novo Nordisk, she optimizes processes for medical devices and combination products. Previously, she held key roles at AstraZeneca, Owen Mumford, and Procter & Gamble. An active RAPS RAC-Devices Committee member, Ola contributes to certification programs and has authored articles for TOPRA on regulatory topics.

Flora is a pharmacist by training. She is heading the team of Health Technology Assessment at the European Commission in DG Health (SANTE), Unit "Medical devices and health technology assessment". The team is responsible for the Legislative Proposal on HTA, for the Secretariat to the HTA Network, and oversees the activities of the Joint Action EUnetHTA. Flora joined the EC in 2006 in DG CNECT, she worked in the ICT for the Health Unit. Before joining the EC she was the Secretary General of the PGEU, the European Association of Community pharmacists and also worked in a community pharmacy.

Ilona Reischl joined the Austrian Agency in March 2006 and is currently an assessor within the clinical trials unit that is responsible for the evaluation of clinical trials with medicinal products and medical devices as well as GCP inspections. Her background is that of a quality assessor of biologics including Advanced Therapy Medicinal products and she is the Austrian member of the European Medicines Agency Biologics Working Party and the Committee for Advanced Therapies. Her regulatory expertise in Clinical Trials, Non-interventional studies, scientific advice and compassionate use procedures reflect a strong interest in the development of biological medicinal products.

Ana is a Senior Scientific Specialist who works as a Product Lead in the Oncology and Haematology Office at EMA. Responsible for clinical and regulatory science input for a portfolio of products from pre-submission of initial marketing authorisation through post-authorisation. Further to this, she worked on the implementation of the IVDR and is currently one of the main point of reference for regulatory guidance on companion diagnostics at the Agency. Previously 2003-2014 Ana worked as Product Team Leader in the area of Quality of Medicines at EMA. Prior to joining the Agency, Ana was a pharmaceutical assessor in the Chemical and Pharmaceutical Technology Division at the AEMPs. Ana has over 20 y. of experience within the Pharma. framework.

Work Experience 2014–present: Senior Manager, Regulatory Devices Group, Sandoz 2012–2014 Head QA Device, Sandoz 2011–2012 QA Device Manager, Sandoz 2010–2011 Registration Manager, Sandoz 2008–2010 QA Manager, Novartis Vacaville 1997–2007 Regulatory Affairs, MED-EL 1994–1996 International Division, Ebewe 1992–1993 Internship, European Collection of Animal Cell Cultures Education 1986–1992 Technical Chemistry - Biochemistry & Biotechnology, Technical University Graz, Diplom Ingenieur

Lilia Luchianov, of the European Commission's DG SANTE, has extensive experience in pharmaceuticals, previously in DG COMP. Currently, she focuses on revising pharmaceutical legislation and is involved in the legislative procedure. Lilia co-authored a handbook on EU Law of Competition and Trade in the Pharmaceutical Sector (2019), lectured on Competition Law and IP Law at the University of Strasbourg, and delivered numerous speeches on pharmaceutical, competition, and IP law. She holds an LLM in European Law from the College of Europe, Bruges, and a Master in Business Law from the University of Strasbourg.

Claudia Popp is the Head EU Regulatory Science & EMA Liaison at Roche. As a senior leader, Claudia has worked for the pharmaceutical industry for more than 20 years and joined Hoffmann La Roche in 2008. She has substantial experience in global regulatory affairs and has held multiple roles within regulatory product development across molecules and therapeutic areas. She combines substantial experience of EMA and FDA processes with a deep knowledge of Health Authority interactions at national level, having held the role of Head Drug Regulatory Affairs at the Roche German Affiliate. The scope of her work includes complex drug/device interfaces.

Rolf Thermann is currently Auditor and Technical Expert with a focus on Companion Diagnostics at TÜV Rheinland LGA Products GmbH. Before joining TÜV Rheinland in 2018 he worked in the Pharmaceutical Industry involved in Antiviral Drug Discovery and as a Head of Product Development for in-vitro Diagnostic Devices.