Abha Raveau Violette

Abha Raveau-Violette has a Masters in Mechanical Engineering from the State University of New York with over 14 years of experience in Combination Products and Medical Devices in Europe and the US.

She has developed, launched, and managed complex endovascular devices and combination products with a wide range of applications. These include prefilled syringes, autoinjectors, stents and stent delivery systems.

Her personal motto is the quote from Maya Angelou, ‘People will forget what you said, people will forget what you did but people will never forget how you made them feel’ and she brings this to life by helping improve patients’ lives by solving complex device problems.
 

Alex Russell

Alex Russell is a Digital Health professional with 10+ years experience in Pharmaceutical industry partnerships, Corporate venture capital, and Startup business development. He is passionate about Emerging technologies and Business model innovation to Transform healthcare.

Alexander Prisacar

Alexander Prisacar is a Scientific Expert for Devices within Boehringer Ingelheim’s Device Technology unit. As a skilled Medical Device engineer, Alexander has experience in the development and lifecycle management of Combination Products in the pharmaceutical industry. He supported the successful launch of Cyltezo®, the first and only FDA-approved interchangeable biosimilar to Humira®.

Alexander has a master’s degree in Mechanical Engineering and Industrial Management from the University of Sheffield. Additionally, he completed the university course “Devices and Combination Products” from the University of Maryland Baltimore County.

With his work at Boehringer Ingelheim, he likes to ensure regulatory compliance to attain a product that is safe for patients to use.
 

Ali Matour

Ali Matour is a highly skilled med tech professional with a solid foundation in Biomedical Engineering. His background spans from research and development to successful product launches. Before joining GSK, Ali worked on the development of Software as a Medical Device (SaMD). Presently, his expertise has transitioned into combination products. In his role as a Device Workstream Lead, Ali has delivered numerous device projects to launch.

Alphons Fakler

Alphons Fakler leads the Human Factors Engineering team at Novartis’ Global Packaging and Device Development and is located in Basel, Switzerland.
Alphons spent the last 20 years of his career in medical device and pharma packaging development. He has worked on many drug delivery device activities like development of subcutaneous and intravitreal PFS, autoinjectors and digital health solutions. Previous areas of responsibility span a wide range from implementing and validating high volume manufacturing lines and parenteral packaging development to medical device risk management, Software as Medical Device (SaMD) and external partner management.
Alphons holds a State Examination Degree in Pharmaceutical Sciences from Ludwig-Maximilian-University Munich.

Anna Sawicki

Anna Sawicki leads the Pfizer Prefilled Syringe Combination Product Development team in Pfizer’s Drug Product Design and Development organization. She has over 25 years of industry experience in large and small molecule manufacturing and device development and manufacturing, the last 11 years have been spent in combination product development. Her current focus is on developing efficiencies across the drug and device development to shorten development timelines. Anna holds a Bachelor of Science in Chemical Engineering from Illinois Institute of Technology and Bachelor of Science in Chemistry from DePaul University.

Annie Zavadil

Bo Kowalczyk

Bo Kowalczyk, the Chief Commercial Officer at ApiJect, boasts nearly three decades of experience in the pharmaceutical and medical device industries. Prior to his current role, he served as Vice President of Sales, North America, at Syngene International, aligning operational expertise with prospecting efforts to optimize client satisfaction. As President at Eurofins Bioanalytical Services, Bo oversaw division strategy, P&L, M&A support, corporate partnerships, and daily operations for large molecule Bioanalysis. As Global Vice President at Eurofins Bioanalytical Services, he integrated services and supported global business development in BioPharma Services. He also held the position of Vice President, Business Development and Marketing at AIT Bioscience, achieving sales and profitability growth by establishing a network of preclinical toxicology service providers. His professional journey and extensive industry knowledge demonstrates his dedication to providing safe and effective medicines to patients in all markets.

Cecile Gross

Cécile Gross is Marketing Global Category Manager at Nemera, focusing on Parenteral Devices. She oversees the product portfolio strategy, development and life-cycle for safety system, pen injector and on-body injector platforms. She has an experience of more than two decades in the Medical Device Industry, marketing BtoB technological products and implementing product lifecycle management for various kinds of devices. Graduated in International Business, she completed her initial training with a master’s degree in Marketing and Management in the Healthcare Industry at IMIS Institute, Lyon France.

Cedric Gysel

Cedric Gysel is a Healthcare Solutions Manager for Johnson & Johnson Design, driving human-centered solutions for patients and customers and leading key innovation projects for device & packaging sustainability as we all product end of life programs across the pharmaceutical and medical device sectors of Johnson & Johnson. He has more than 15 years of experience with the development and design of devices and combination products. He holds a bachelor’s in pharmaceutical technology from the University of Basel and a master’s in medical device technology from the University of Applied Science.

Charles Potter

Charles has more than 30 years experience in the drug delivery industry. He has been employed for the last four years as part of the device development team at Chiesi, an Italian family owned pharmaceutical company with a turnover of ~€3bn. Chiesi is a leader in respiratory medicines and has an expanding range of rare disease products which utilize a range of delivery technologies.

However, most of Charles’ career has focused on novel injectable technologies. Following an engineering degree, Charles joined PowderJect Pharmaceuticals and saw it grow from 4 to >1,000 employees. He then founded and was CEO of Glide Pharma for 12 years before working as an independent consultant with a portfolio of companies which were either developing a proprietary drug delivery technology or were selecting a delivery technology for their novel compound.
 

Chris Muenzer

Chris Muenzer is the Vice-President of Innovation and Development at Haselmeier. He leads a team of experts that create customized drug delivery systems for pharmaceutical and biotechnology companies. He has over 18 years of experience in the pharmaceutical and medical device industry, having worked at Novartis, Roche and the Battelle Memorial Institute. During this time, he has worked at all stages of device development from initial concept, engineering development, clinical trials and launch. Mr Muenzer holds a BSME from Carnegie Mellon University in Pittsburgh (PA, US). He is also the inventor of several patents and is a frequent contributor to industry conferences and ISO standards.

Cinzia Rotella

Cinzia holds a degree in Materials Science and a PhD in Polymer physics from the KULeuven University. She has joined Sanofi in 2016 as a Sr. Materials Scientist and she is now Project Leader for Life Cycle Management activities in the Medical Device Unit.

Claus Geiger

Education:
Pharmacist, PhD, MBA (Henley Business School), Qualified Person according to EU Regulations and holder of various expert qualifications.
 

Professional Experience:
Worked for top ten global pharma companies Roche and Sanofi. He has held various roles in the field of injectable drug delivery systems for biotherapeutics with expanding responsibilities: QA/QC, Manufacturing, Supply Chain, Key Account Management of device partner companies, Global Medical Device Surveillance, Global Device Project Leader and Drug Device Integrator.
 

Special interests:
Drug Device Integration during the R&D and Industrialization phases of novel biotherapeutics, Drug Device combinations with connectivity, sustainability, establishing and working with cross-functional diverse teams.
 

Claus-Juergen Maier

Claus-Jürgen Maier is an Environmental Expert, leading waste and circular economy for industrial waste and products end of life at Sanofi. He has more than 17 years of experience within the field of health, safety, and environment (HSE) at Sanofi and Infraserv Höchst within local and global positions. This includes the role as Emergency Manager Campus Höchst, HSE team lead R&D Frankfurt, HSE business partner for the biologics platform and most recently as eco-design project lead for Sanofi. Claus-Jürgen holds a master and a PhD in Chemistry, both from the University of Heidelberg.

Courtney Soulsby

Courtney Soulsby works as a Global Director for the Healthcare and Life Sciences sector team for BSI (British Standards Institution), focusing on healthcare sustainability. Courtney has worked with pharmaceutical and med tech industries and their supply chain for over ten years – with a deep understanding the issues with regulation, environment, security, compliance, quality, and other risk exposures when manufacturing and transporting healthcare products.

Cristiana Heese

Education: Master Degree in Chemical Engineering from Royal Institute of Technology (KTH) Stockholm, Sweden.

Since 2021, I have held a Packaging Engineer position for Combination Products at Boehringer-Ingelheim within the Manufacturing Science and Technology -Packaging group. Prior joining Boehringer- Ingelheim, I had the opportunity to work for global R&D organizations of Johnson& Johnson, Essity and Freudenberg Group.

As a scientist in R&D organizations, I have gathered a deep experience in product development and innovation of Feminine Hygiene Products, Tissue Products, Personal Protective Equipment, Medical Devices and Packaging for Medical and Combination Products.

I led the development of innovative products with the end-to-end responsibility, doing pre-studies in the front-end area, qualifying products with consumer, coordinating product testing and simulations, but also supporting technical transfer and commercialization from development stage to manufacturing.
 

Daanish Ahmed Khan

Daanish is a seasoned technology leader with a solid track record from MedTech industry including hearing aids, ostomy care etc. He is currently serving as the Director for Connected Solutions & Integration where he is responsible for the engineering function to bring the connected solutions in various therapeutic areas such as Diabetes, Obesity and Rare Diseases to the market.

Daanish has a M.Sc. in Wireless Communication from University of Aalborg, Denmark and executive certificate in Systems Engineering from MIT Cambridge, U.S.A.
 

David Harrison

David J Harrison is a business lead, operations head, novelist, and senior director within biopharma and medical devices, although not necessarily in that order. Amongst his sources of inspiration, he lists his wife and family at the very top, not too closely followed by Vonnegut, Murakami, and Bowie.

Over the last twenty-five years, David is delighted to have contributed towards some important medicines, most of which require novel and innovative medical devices, often surrounded by carefully designed eco-systems. He believes in the power of partnerships to create lasting value for patients.

David was the joint recipient of the 2020 PDA Innovation award. His first novel, Recursion, was published in 2021.

You can follow David on LinkedIn (linkedin.com/in/harrisondavid), and Instagram (@davidjharrisonwriter).
 

Elise Legendre

With 20 years of experience across pharma, Elise currently serves as Head of primary container and safety system development in medical device at Sanofi.
Elise is responsible of leading the drug integrated product development for biologics, small molecules an vaccines on prefilled syringe based delivery system. Her group is mainly leading the operation of the PFS development and the transfer of the developed container and safety system to R&D center and manufacturing groups. Before this position, she was supporting various medical devices combination products, such as auto injectors, prefilled syringes projects as PFS expert and project manager.

Prior joining Sanofi, Elise was GSK’s packaging head on an industrial site in Normandy. She was managing the LCM activities on primary, secondary packaging.
Before this, Elise worked in Aseptic and Packaging manufacturing area as operational manager where she served in various roles focused on manufacturing, product commercialization and operational excellence.
 

Fatima Bennai-Sanfourche

Dr. Fatima Bennai-Sanfourche is working currently as Global 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, Medical Device Safety Global Pharmacovigilance/Medical device Safety officer.

She has more than 20 years of experience in the quality management, Regulatory Affairs and development of medical devices and combination products.

She studied Biology with a focus on Biochemistry, Immunology and Pharmacology, and did her PhD in Pharmacology and Pharmacochemistry in Strasbourg in 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 by 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, incl. accordance with medical device Good Clinical Practice (GCP).

She is also leading the project of the implementation of MDR for PH-Bayer AG.

She was nominated in 2019 by the European Commission as EFPIA observer for the PMSV (Post-Market Surveillance and Vigilance) subgroup (GROW.D4) responsible for the implementation of these process according to the medical Device regulation.

Since July 2021 she is also a member of the European Commission Post-Market Surveillance (PMS) task force responsible for the preparation of the MDR PMS guidance according to the Article 83.

George Moore-Arthur

Following an BSc in Biomedical science and MSc in Biotechnology I am currently working at Novo Nordisk as a global regulatory professional responsible for driving regulatory strategy in key global markets for Novo Nordisk digital health & IVD products. Prior to joining Novo Nordisk, I worked for the UK regulatory agency (MHRA) in various roles including medicinal pharmaceutical products and safety & surveillance for a range of medical devices (including surgical, wound management and IVD devices).

Hans Jensen

Hans is leading the business development efforts for the Drug Delivery sector at Cambridge Design Partnership. He is an experienced industry expert within drug delivery devices and has a broad understanding and hands on experience from early conceptual work to implementing high volume manufacturing lines. Working with major Biopharma customers he has worked with most parenteral delivery systems such as pen injectors, infusion pumps, OBDS devices - including managing a successfully launched FDA cleared connected Auto Injector system.
Hans holds a Bachelor’s degree in Electronics Engineering as well as an executive MBA from Henley Management College.
 

Heinrich Martens

Heinrich Martens, VP Regulatory Affairs, with more than 15 years of experience working in Regulatory Affairs / Medical Devices. In his carrier, Heinrich Martens, was leading and being responsible for the various Regulatory Affairs projects – e.g. implementation of the Medical Device Regulation, leading and building up RA teams. Leading an international team, across the globe, and being in contact with Authorities, Notified Bodies and Regulators – is one of his key topics, within his current role. Beside his work, he spends time and supports social projects. Traveling and time with his family is also important.

Jacopo Michieli

Jacopo Michieli has close to 15 years of experience in development of primary packaging for pharmaceutical use.

Holding various positions in Stevanato group for over 10 years, he has significantly contributed to the design and industrialization of innovative Primary packaging.

He also managed the packaging operations transition of medical device in USA while working at the Innovation Site of Philips in Eindhoven.

In 2019 he joined CSL Behring in Bern as Sr. Device Engineer supporting the introduction of combination products and defining new syringe platforms.

He has a Mechanical Engineering background and a degree on “Economics and Management” from Venice University.
 

Joel Richard

In the past 30 years, Joël has held global leadership positions in various biotech and pharma companies such as Ipsen, Merck Serono and Ethypharm. Most recently Chief Development Officer of MedinCell, he led all the Drug Development operations of the company including clinical, regulatory and quality activities. Previously, Joël was Senior Vice-President, Pharmaceutical Development for peptides & small molecules at Ipsen. A graduate from Ecole Normale Supérieure (Paris-Saclay), Joël holds a PhD in Materials Science/Colloids & Interface Science from Paris 6 University and “Habilitation à Diriger les Recherches” from Bordeaux 1 University.

John Merhige

John A. Merhige is Chief Commercial Officer at Credence MedSystems, leading the Company's commercial activities and external collaborations. Previously, John was Vice President, Market Development at Sanofi. He came to Sanofi upon its acquisition of Pluromed, which John joined in its early stages and where he was a member of the executive management team leading the Company’s sales and marketing efforts. Prior to Pluromed, John founded Prelude Devices to target early-stage medical device technologies for development and commercialization.

Julian Dixon

After 24 years at Team Consulting supporting the development of drug delivery devices, Julian joined AstraZeneca biopharmaceutical development in 2022 to be in one of the key player organizations as the future of combination product human factors is being shaped. Julian’s background is in mechanical engineering and psychology. Both have remained fascinating and provide more than enough fuel for continued curiosity.

Kyle Berman

Kyle has a degree in Mechanical Engineering and over 10 years’ experience in design and engineering. His early career focussed on the development of tractors and heavy machinery before moving onto medical devices in 2016.

During his time working for Pfizer’s Devices Centre of Excellence he has been the Technical Lead on a selection of electromechanical device projects. He is involved in suitability assessments, specification setting, product development and verification testing from early-stage design through to pre-production.
 

Through his work on ‘smart’ injector projects, Kyle has acquired an interest in connected devices and how they can be utilised to improve Patient-Device interactions.

 

Louisa Harvey

Louisa founded Harvey Medical Consulting in 2012, having worked in the pharmaceutical and medical device industry for over 15 years. She is passionate about usability of medical devices and, in 2018, co-founded Medical Human Factors Network whose mission is to raise the bar of human factors work in the UK. Louisa spends time both in the UK office and The Netherlands office.

Louisa also regularly presents at international conferences on the subject of device usability and ethics. Louisa has an MSc in Industrial Pharmaceutical Science and is an accomplished moderator, facilitating on average 600 interviews a year. Her project experience spans across many different products areas, from handheld auto-injectors through to large surgical systems. Louisa’s personable, can-do attitude and determination to get to the bottom of clients’ business questions, ensure that every project is a success!

Louise Place

Originally training as a pharmaceutical scientist, Louise has over 14 years’ experience in drug delivery & medical devices with a focus on device technical management and regulatory strategy for EU & FDA submissions.
Louise joined GSK in May 2020 and leads the Device team within CMC Regulatory with responsibility for global regulatory and advocacy strategy (Devices) across the GSK portfolio.
With a solid background in inhalation and parenteral ‘combination products’ from concept to market through previous experience working at Pfizer, Oval Medical Technologies, and Cambridge Design Partnership, among others, Louise has a proven track record in supporting successful device submissions for different device types and markets.

Mark Hassett

Mark Hassett, Vice President of Business Development, Credence MedSystems, Inc.
Mr. Hassett has 30+ years’ experience in the medical device industry. In that time, he has functioned as Global VP Sales, Marketing, and Business Development for IVAC Corporation, Block Medical, Medication Delivery Devices, Safety Syringes, Venetec Int’l, Unilife Medical, and ROVI Contract Manufacturing (EU).
His responsibilities included commercialization of infusion pumps, injectable devices (PFS), wearable devices, and autoinjectors.
He has injectable device experience in multiple markets to include, acute care, alternate site, and more specifically for Pharmaceutical and Biotech the last 20 years.
He holds a BS degree from Georgia State University in Atlanta, GA.
 

Matthew Jones

In his role as a Senior Sector Manager, Matt leads key projects within the Medical and Scientific Sector at DCA and works at a strategic level to help ensure that the Sector continues to develop and deliver success for DCA's clients.

A mechanical engineer by training, he has over 20 years' experience in consultancy and is a specialist in the development of drug delivery devices. He has extensive experience of leading multi-disciplinary teams and supporting clients through the all stages of the development process: from devising product strategies and roadmaps, through design and evaluation and on to detailed support of industrialisation and beyond.

Matt has device development experience that covers a wide range of technologies and routes of administration and as part of the talented team at DCA, has worked to deliver a number of multi-award winning and successfully marketed devices.
 

Montse Jansa

Montse Jansà is the Managing director in Merck Denmark with a strong background in pharma industry. With over 25 years of experience, Montse has proven expertise as a dynamic leader who delivers strategic thinking and goal setting.
Currently serving as the Managing Director in Merck Denmark, she is responsible for promoting and leading Merck footprint in Denmark, by leading local activities and gathering teams and functions around driving a high-performance culture, business transformation, and thriving in a challenging market access environment. Under her leadership, Merck Denmark has evolved into a more diverse and inclusive organization, with a strong focus on teamwork and feedback culture. We work hard everyday to bring more innovation and faster to Danish patients.
Prior to joining Danish team, Montse held several key positions in medical and commercial areas, including marketing manager, sales manager and Business Unit Head in Pfizer, Gilead and Merck.
Montse holds a degree in Biology from University of Barcelona, as well as a Master in General Management by IESE and several curses in leadership, digital business and communication and negotiation. She is also member of WILD, Women in Pharma and ADE.
Passionate about diversity in its broadest sense (gender, cultural and generational) and build up high performance teams.
In her free time, Montse enjoys hiking, reading and cooking.
 

Nicola Coles

Nicola has been with BioPhorum since 2019. Initially focusing on raw materials, she has worked cross-phorum to connect the technical, supply chain, and regulatory experts to develop a strategy to future proof raw materials for the biologics industry. She now leads the newly launched BioPhorum Sustainability and is excited by the challenge to connect people from all disciplines across the industry around this critical topic.

A change program leader with over 25 years of management and consulting experience, Nicola has supported private and public sector organizations to improve results by aligning motivation, behaviors, and processes. Her passion is creating the link between executive strategy, technical capability, and front-line delivery, and developing comprehensive change programs underpinned by behavioral science techniques.

Her extensive project and change experience has been in banking, telecommunications, pharmaceuticals, and public services. As a result, Nicola has a wealth of insight in overcoming common change barriers, as well as deep expertize in industry specific challenges.
 

Niels Otterstrom Jensen

Niels Otterstrøm Jensen has a long standing experience in the pharmaceutical sector. After many years working within supply chain management in Novo Nordisk, he changed his position to Corporate Environmental Strategy in 2020, where he is Head of TakeBack Program. He is now leading a small team working on establishing take-back pilots of used injection pens. Until now take-back pilots have been launched in Denmark, UK, Brazil and France.

Oli Gould

Oli Gould is an experienced Design Manager with a background in engineering and 10 years working in medical device development, preceded by several years working with household consumer technology brands. As R&D Sustainable Solutions Lead at Owen Mumford, Oli supports the development of innovative new medical devices. Alongside a range of competences, Oli specialises in engineering analysis and environmental sustainability in product development.

Pascal Lagorgette

Pascal Lagorgette is Head of Product Development at Gerresheimer Advanced Technologies division in Switzerland. In this position he leads a team responsible for the development of smart on-body injectors. His passion for user-centric design, plus extensive experience developing innovative mechatronic devices, enable him to ensure that Gerresheimer’s solutions meet the needs of users and customers.

Peter Harley

Peter leads the Technology Group in Crux, containing the Applied Sciences and Electronics & Software teams. Working within the top pharma companies, he has supported projects across a wide range of topics related to challenges with injectable systems, as well as classic device design and development. With an enthusiasm to integrate the latest technology into device development to reduce time to market, he is experienced in supporting the inclusion of digital/simulation test data as regulatory evidence, as well as exploiting the latest scientific capabilities to unlock new insights to drive an enhanced patient experience.
Peter comes from an analytical research & development background, with a Masters in Mechanical & Manufacturing Engineering, a PhD in Turbomachinery Engineering, and 12 years of experience spread across automotive, consumer electronics, and medical devices.

Richard Crowther

Richard has experience with a variety of companies (Procter & Gamble, GSK and Merck) but has spent the last 19 years with Amgen at the Thousand Oaks facility in California before recently moving back to the UK. At Amgen, Richard has lead teams in the engineering function, supporting drug substance manufacturing and later moved into process development, supporting drug product manufacturing. With his move back to the UK, Richard joined regulatory affairs, supporting device projects in the EU.

Sanjay Kumar Rout

Relevant experience and Expertise : I have 17 yrs experience in Drug product manufacturing and Packaging, Combination device ( Pen and Autoinjector, NSG) development, process validation and commercialization, shipping validation. Expertise in Visual inspection, Packaging and medical device design and development , technology transfer and DHF filling.
 

Qualification: Bachelor in Pharmacy
 

Sean McPike

Sean worked in several heavy manufacturing industries before joining Eli Lilly in 2004, subsequently moving to a Global HSE role in 2007. Since that time, Sean has held a variety of Global Environmental Management roles including Subject Lead for Lilly’s EU & Asia Environmental Regulations and Lilly’s Global Chemical Regulations Compliance process. More recently, Sean is the Global Lead for Product Stewardship and Extended Producer Responsibility supporting Lilly’s Affiliates, Formulation, Packaging and Device Manufacturing facilities.
Sean is a member of the EFPIA EHS Expert Group and ABPIs SUSTAIN Group.
Sean received an MSc in Health, Safety and Environmental Management from University of Glamorgan in 1995 and gained Charter Environmentalist status in 2015.
 

Steve Hoare

Steven Malbon

Steven Malbon is a professional with 9 years of experience in the medical device industry. He currently serves as the Combination & Physical Devices Manager at Medical Engineering Technologies Ltd, where he oversees medical device testing projects from clients all around the world and is committed to ensuring that all products meet the highest standards of quality. In addition to his work at Medical Engineering Technologies Ltd, he is also a member of ISO Technical Committee 84, contributing to the advancement of medical device standards globally.

Theresa Scheuble

Theresa Scheuble is Head of Design & Innovation for Johnson & Johnson. She is an expert on combination product requirements and considerations supporting all segments of Johnson & Johnson.

Prior to her current role, Theresa was Head of the Combination Product Drug Delivery Systems Development for the East Coast team in Janssen, a Johnson & Johnson Company. While at Janssen, Theresa was responsible for Combination Product Device development and led cross-sector initiatives. Theresa has been with Johnson & Johnson for greater than 25 years, working in all Segments of Johnson & Johnson with 18 years specifically in the Medical Device Segment. She was the project lead and technical lead for greater than 20 portfolio enhancing products by Johnson & Johnson companies. She also has experience in the Automotive and Aerospace industries.
 

Thomas Wejs Moeller

Thomas is the Senior Director of Regulatory Affairs for Devices at Novo Nordisk and is responsible for devices and combination products.
He has extensive experience with regulating medical devices in Denmark and Europe, and he comfortably balances between business aims and regulatory demands.
As a former Director of Medical Devices in the Danish Medicines Agency and an MDCG member, he has worked with the public sector, MedTech-Industry and Patient-organisations to secure patient safety.
Thomas has been elected Chair of the Competent Authorities for Medical Devices (CAMD). And has experience in national and international arenas—Europe with the EU commission, EMA, Notified Bodies, Authorities, and patient organisations.
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.
 

Tina Arien

Albertina (Tina) Ariën is Principal Scientist in the Drug Product Development organization of Johnson and Johnson Innovative Medicine R&D in Beerse, Belgium. She has over 25 years of industry experience in small molecule formulation and process development. Her expertise is in liquid formulation development for oral and parenteral applications. The past 16 years she has worked on development of age-appropriate pediatric formulations. Her current focus is on developing complex injectable products such as long acting injectables and lipid-based formulations. Tina started working at J&J after a 2-year post-doctoral fellowship at the University of Nottingham. She received her Ph. D in Biomedical Sciences from the University of Bordeaux II. She graduated as a biochemical industrial engineer from University Hasselt.

Ulrich Stahl

• Dipl. Ing / Mechanical Engineering at the technical university of Darmstadt
• Project engineering and concepting for automation of injection moulding systems
• Concept development and project engineering for cam operated assembly equipment / medical device industry
• Director New Technologies at Harro Höfliger focussing on pharmaceutical and medical device industry products