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Program Committee

Who We Are

David Haerry

Patient Advocate

European AIDS Treatment Group Brussels

Bio

David Haerry is a member of the 2021 Medtech & Pharma Program Committee (Committee Member since 2019) and has been a treatment writer and conference reporter since 1996. He co-authors a database on travel and residency restrictions for people living with HIV, www.hivtravel.org David is Secretary General for the Swiss Academic Foundation on Education in Infectious Diseases SAFE-ID, a core team member in the Patvocates Network and a member of the Executive Team at the Patient Focused Medicines Development Initiative. He is involved with the European Patients' Academy on Therapeutic Innovation Innovative Medicines Initiative project EUPATI-IMI since 2012. In the current EUPATI project, David is co-chairing the Futures Group and he is Work Package leader in EFOEUPATI-IMI. David Haerry has also been involved in the working group updating the CIOMS International Ethical Guidelines for Health-Related Research involving Humans published in December 2016. From 2013 to 2016, he co-chaired the Patient and Consumer Working Party at the European Medicines Agency. In Switzerland, David Haerry is the co-chair of the Swissmedic working group for patient and consumer organisations. He is a member of the ELSIag at the Swiss Personalised Health Network, the Expert Committee on Cancer Screening, the Data Ethics Board at the MIDATA cooperative midata.coop and a board member for the UNALONE Association. He is the founder and Chair of Positive Council Switzerland and he is closely involved with the Swiss Hepatitis Strategy. David has been involved in HIV and hepatitis C virus (HCV) drug development since 2005, as well as being active in HIV/AIDS-related aspects of regulatory affairs, research ethics, personalized medicine, risk communication, pharmacovigilance, observational studies, biomedical prevention and research. He has co-authored a number of peer reviewed publication in infectious diseases, doctor-patient communication and pharmacovigilance. David has been living with HIV since 1986.

Ruth Foster

Director Medical Device and Digital Health EMEA

MSD

Bio

Ruth Foster is a Member of the 2021 Medtech & Pharma Program Committee. She studied Chemistry in the UK and has worked in the medical industry for over 35 years. She started out in in vitro diagnostics (IVDs), followed by pharmaceuticals, then 14 years with a Medical Device company and now she has been working with MSD for just over 4 years in the area of Drug Device Combination products, Digital Health Solutions and Companion Diagnostics. She chaired the Blood Safety Group at Eucomed (now MedTech Europe) when she worked for the Medical Device company and she is now the EFPIA representative to the European Commission’s Medical Device Coordination Group (MDCG) New Technologies and Software sub-group.

Mike Wallenstein

Global Head MDR Implementation & DD&C Compliance

Novartis

Bio

Mike is Global Head Novartis MDR Implementation & DD&C Compliance at Novartis Pharma AG since April 2019. In this role, Mike oversees all activities related to the EU MDR implementation for Medical Devices & Combination Products at Novartis globally. Mike leads the Medical Device and Combination Product Expert Network at Novartis, and is a member of several US and EU Expert Committees and Interest Groups on Combination Products Prior to this position Mike was Executive Director QA / Senior Compliance Officer (GCA) for four years, overseeing all compliance activities related to Medical Devices & Combination Products at Novartis globally. He joined Novartis in 2010 as Global Auditor in Group Compliance and Audit. Before joining Novartis, he was Director Global Audit Systems at Gambro Renal Care (today Baxter) and European Head Quality Systems & Audits at 3M. He studied Chemical Engineering and Plastic Technologies in Münster, Germany, and has over 25 years of experience in QA, R&D, and Manufacturing within the Medical Devices & Pharmaceutical Industry.

Daniel Delfosse

Head Regulatory Affairs

Swiss Medtech

Bio

Daniel Delfosse is a member of the 2021 Medtech & Pharma Program Committee and Head of Regulatory Affairs at Swiss Medtech. His mantra is “Innovation despite Regulation” and he tries to create a regulatory framework in Switzerland that will allow innovations to be developed without unnecessary hurdles but still respecting the product safety aspects. He spent the last 20 years in the orthopaedic industry as head of development and head of innovation at Mathys Ltd Bettlach. As Product Safety Officer, he was also responsible for the controlled introduction of innovative medical devices. He has a Diploma in Materials Engineering from ETH Zurich and the Ph.D. from EPF Lausanne followed by a research fellowship at the University of British Columbia in Vancouver, Canada.

Marisa Papaluca

Visiting professor

Imperial College London

Bio

Marisa Papaluca Amati, MD, graduated in 1978 at the State University ‘la Sapienza’ in Rome – Italy with a research focus on clinical immunology. She specialized in internal medicine and continued clinical work till 1994. Marisa joined the Pharmaceuticals department of the Italian Ministry of Health and in 1990 established the first Office for Centralized Community Procedures (OCCP), focusing on the regulatory evaluation of r-h-DNA medicines at European and international level. In 1994, Marisa moved to London and was thefirst recruited scientist at the EMA: she pioneered the new EU medicines system, pursuing the integration of innovation in medicines and leading regulatory science initiatives in genomics, cell and gene therapy, biomarkers, nanotechnology, personalized medicine, innovative clinical trials designs, pharmaceuticals and devices combination products. On these themes Marisa created and led safe harbors such as the EMA Innovation Task Force and the Business Pipeline service and established the EMA specialized scientific support office. Appointed as the first EMA Senior Scientific Advisor, she played a key role in establishing the EU Innovation offices Network across Member States, the pilot EMA Regulatory Science Observatory and the EMA Regulatory Science Strategy to 2025. Marisa published extensively on relevant themes with chapters in books and articles in peer reviewed scientific journals. She has been also panelist, speaker and chair in EU and international conferences, workshops and seminars. Lecturer since 2008 in the faculty of medicines of the Tor Vergata University in Rome, she was awarded in 2016 the status of Emeritus Professor. In 2019, Marisa joined the Public Health and Primary Care department at Imperial College London, and is an invited expert at WHO (science division) and European Commission (Research and Innovation Directorate).

Eldin Smajic

Head of PFS Engineering

Roche Pharma

Bio

Eldin’s current role is Head of Pre-Fillable Syringe (PFS) Engineering in Device and Packaging Development at Roche Pharma. He and his team are driving innovation and technical development of primary packaging solutions such as PFS or large volume cartridges within Roche’s Medical Device and Combination Product portfolio. Eldin is an engineer by training with a Master of Science (MSc) from the Swiss Federal Institute of Technology (ETH) in Zurich. After obtaining his MSc he successfully completed a didactical-pedagogical education at ETH and was teaching at the ZHAW School of Engineering in Winterthur. Following his short academic endeavor, he gained over 12 years of experience in the Medical Device and Pharmaceutical Industry through multiple roles. His professional career started by joining Roche Diagnostics (Diabetes Care) as Technical Project Leader R&D for insulin infusion devices and its accessories. In 2013 he then joined CSL Behring’s Engineering Department as Project Leader for large capital investment projects in the field of aseptic manufacturing including sterile filtrations, pharma automation and cleanroom design. Eldin returned to Roche in 2016 as Project Leader for commercial Device Combination Products, Medical Devices and SaMDs in the Pharma Technical Device Development organization. In late 2019 he took over his current role and enjoys working together with a diverse talented team of engineers and scientists.

Christiana Hofmann

Regional Manager Focus Topics Article 117 & Annex XVI MDR

TÜV SÜD

Bio

Christiana Hofmann is a Biologist with a main interest in the biomedical area. She completed her PhD at the Helmholtz Research Centre of Munich in cooperation with the Technical University of Munich in the field of Toxicology with focus on risk analysis. After gaining several years of experience in the pharmaceutical industry, e.g. Novartis, she joined TÜV SÜD in 2016 as a team lead of experts and auditors for non-active medical devices. In between she has taken over the role of the Regional Manager Focus Topics. Where she is overall responsible for Article 117 and Annex XVI in the DACH & Nordics region. Two fields where she can combine her passion for biomedicine and her experience in medical devices gained over the past years.

Marta Swierczynska

Senior Manager Regulatory Affairs

SFL Regulatory Affairs & Scientific Communication

Bio

Marta Swierczynska is a member of 2022 Medtech & Pharma Program Committee. As a Senior Manager Regulatory Affairs at SFL Regulatory Affairs and Scientific Communication, she leads and supports regulatory projects for medical devices, IVDs, and combination products, with the focus on implementation of the EU Medical Devices Regulations. She specializes in clinical evaluations, particularly in the area of dental products.

David Haerry

Patient Advocate

European AIDS Treatment Group Brussels

Ruth Foster

Director Medical Device and Digital Health EMEA

MSD

Mike Wallenstein

Global Head MDR Implementation

Novartis

Marta Swierczynska

Senior Manager Regulatory Affairs

SFL

Daniel Delfosse

Head Regulatory Affairs

Swiss Medtech

Marisa Papaluca

Visiting professor

Imperial College London

Eldin Smajic

Head of PFS Engineering

Roche Pharma

Christiana Hofmann

Regional Manager Focus Topics Article 117

TÜV SÜD

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