Chemist and Cosmetologist, owner and founder of Angel Consulting-Milano, Safety Assessor himself, he leads a team of 12 Safety Assessors in his company. Angel Consulting participated to EU funded projects: Superflex and Pepticaps. Now it is partner of Life Vermeer project, intended to develop new in silico tools for the safety assessment of ingredients. Their activity is focused on international Regulatory compliance as well as they are involved in several research projects where companies and research centers are involved. Co-autor of Harry’s Cosmeticology, he wrote the chapter concerning EU and US regulations, and he is in charge for updating the topic. Angel Consulting is partner of the Italian Cosmetic Companies Association (Cosmetica Italia), in charge for consultancy, training and safety assessments since more than 15 years. He takes lessons of cosmetology and safety assessment at the Universities of: Siena, Genoa, Rome-Tor Vergata, Tel Aviv.

Roberto Scazzola received his Master’s Degree in Environmental Sciences from the Italian University of Venice in 1997.  As Scientific Policy Officer of the Consumer products Unit EU Commission, Roberto is responsible for the implementation of EU Cosmetic products Regulation including managing the Borderline products Working group.

His expertise in the public sector stems from 5 years’ experience in the European Commission (Chemicals Unit) and 7 years’ experience as Head of the Waste and Soil Bureau in the Environmental Protection Agency in Italy.

Roberto was also appointed Technical and Scientific affairs Director at AISE (International Association for Soaps, Detergents and Maintenance Product) 3 years.

Dr Smith graduated with a M.Chem (Hons.) degree in chemistry and an interdisciplinary PhD. between chemistry and genetics. Before joining NATRUE in 2014, he worked in research covering biotechnology (Leeds, UK) and the biomedical/pharmaceutical sector (Montréal, Canada). In July 2016 Mark was appointed by the NATRUE Board to Director General of NATRUE where he is in charge of the day-to-day running of NATRUE, and plays lead role in all political, regulatory and scientific affairs of the association – advocacy, research and label.

Sanjay Talreja is an expert regulatory toxicologist with 8 years of experience in consulting toxicology. He is Registered Pharmacist with Gujarat State Pharmacy Council, India, Master’s in Pharmacology and Toxicology, a Member of Royal Society of Biology and EUROTOX registered toxicologist (ERT). Currently, he is associated with Intertek as Assistant Manager, Regulatory & Toxicology Services in Health, Environmental & Regulatory Services (HERS) department. His broad area of expertise in various areas of regulatory toxicology includes: Raw material qualification for personal care products and Cosmetics products safety report (CPSR) for global markets. He is a specialist for Health Based Exposure limits (HBELs) for Pharmaceutical APIs and reactive intermediates. His professional expertise also encompasses toxicological risk assessments for Biocide products, detergents and cleaning products, general products, and toys.

Biologist engineer since 2014 and specialized in the development of industrial products, Ségolène DE VAUGELADE wanted to supplement her knowledge  in analytical chemistry during a CIFRE thesis in collaboration with EXPERTOX Laboratory in Paris and the Molecular Chemistry laboratory (LCM) part of the Chemistry Department of the Ecole polytechnique . During 3 years, she learned to use different types of mass spectrometers and developed her skills in validation methods and quality control of cosmetic emulsion. Enriched by her previous experiences, she now has a global vision of the parameters necessary for the evaluation of cosmetic products ranging from chemical, physical and microbiological analyzes, to monitoring the quality control from conception to sales. Since 2018, Ségolène has been the R&D manager at EXPERTOX Laboratory.

Mika Reinikainen is a founder and Chairman of the European Association of Authorised Representatives (EAAR).
He is the founder of Abnovo Ltd, a medical device consulting company. Previously, he served in the position of Vice President at Quintiles. His company focuses on regulatory strategy and compliance, as well as resolving manufacturers’ conflicts with Notifies Bodies and Competent Authorities. He also provides regulatory interpretation and advocacy, in particular on borderline determination between legal regimes.
Mr. Reinikainen has more than 30 years of experience in the European medical device field: as regulatory affairs manager in industry (Pfizer Hospital Product Group of companies), as healthcare legal counsel (Hogan & Hartson) and as as a regulatory consultant (Medical Technology Consultants Europe, BRI and Quintiles).
He was directly involved in the development of the Medical Devices Directives (chairing the working group that developed the European medical device classification system and later as a consultant to the European Commission on classification) as well as through various roles in trade associations. He also served as the former Chairman of CEN TC 257 (technical standards).
Mr. Reinikainen is currently a member of the European Commission’s Medical Device Expert Group and of the Commission’s Working Groups on Borderlines and Classification, Software and New & Emerging Technologies. He is a former Vice President, Europe, of the Regulatory Affairs Professionals Society (RAPS).
He holds a Master’s degree in law from the University of Nice (France) and a Master’s degree in Business Administration from Wharton (University of Pennsylvania, USA).

Dr. Bassil Akra is the CEO and co-owner of QUNIQUE GmbH, a medical device and in-vitro diagnostic consultancy company, located in Germany and Switzerland. He spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and the globally the notified body association in the various European discussion. Dr. Akra was the Vice President for strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH in Germany. He has long experience in leadership, business management, research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. Dr. Akra played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.). He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR) and their impact on the EU healthcare system.

Ronald is currently busy assisting Emergo clients to prepare for the MDR. He assists in developing and implementing regulatory strategies, corporate policies and complex change processes related to MDR compliance. He is also helps companies finding a suitable notified body, sometimes with very short timelines. Over the last few years he has been member of the Eudamed Steering Committee and several of the Eudamed working groups. He expects the coming year Eudamed implementation will require a lot of his attention. He started working for Emergo in 2013.

Before working for Emergo Ronald was a Senior Inspector at the IGZ, the competent authority for medical device for The Netherlands. As an inspector he has been involved in routine inspections of manufacturers of medical devices and IVD’s. He has worked on many market surveillance cases and on projects in which technical documentation of a cohort of manufacturers was linked to actual market experience in hospitals or other environments. He has represented The Netherlands in several working groups of the European Commission, like the MDEG on Borderline and Classification, the COEN working group and Eudamed. He has worked for the IGZ for more than 11 years.

Ronald compares Regulatory work with flying a plane: a good pilot can land his plane in a storm; an excellent pilot does not end up in bad weather. This summarizes well how he likes to navigate on behalf of the clients he works with.

Maria E. Donawa, MD is President, Donawa Lifescience, headquartered in Rome, Italy, with over 30 years’ regulatory experience, including six years with the US FDA, in the area of medical device regulation. Donawa Lifescience provides US and European quality system, regulatory and clinical services to life science companies worldwide.

Dr Donawa is an active member of the ISO study group responsible for the development and revision of ISO 14155, the international standard for medical device clinical investigations.

She is also a stakeholder observer to the Clinical Investigation and Evaluation (CIE) Working Group. The CIE assists the Medical Device Coordination Group (MDCG) on issues relating to clinical investigation and evaluation of medical devices in accordance with the MDR.

Dr Donawa has US degrees in pharmacy and medicine, with post-doctoral specialization in clinical and anatomical pathology.

Member of the Executive Group of the Competent Authorities for Medical Devices (CAMD), Head of Department of Medical Devices, the Swedish Medical Products Agency, Sweden

Helena Dzojic holds a PhD in Clinical Immunology from Uppsala University and has nearly five years of research experience within the field of immunotherapy. Since 2011 she has held the role of Head of the Department for Medical Devices at the Medical Products Agency in Sweden where she has had several roles since 2007. Helena also has broad experience in the field of regulation and market surveillance of medical devices. She is member of Medical Device Coordination Group (MDCG).

Sandra Ferretti is the EAAR liaison officer and Chief Compliance Officer and Public Affairs Director at Obelis, a leading authorized representative based in Brussels. She represents the EAAR at various EUDAMED sub-groups (actors registration, device registration, vigilance, data-exchange), and also now at the MDCG work group on UDI, Vigilance, and IMDRF.

Anne Jury is a consultant and trainer in medical devices EU & UK regulatory compliance and quality assurance systems.  Starting out as company microbiologist for Smith & Nephew Textiles Anne went on to work for Notified Bodies, BSI and then TÜV Product Service as a lead auditor and later as UK Regional Manager.

Anne has run her own consultancy business since 2000 providing medical device regulatory support to companies ranging from research institutes and start-up companies to SMEs and multi-national market leaders.  Anne was one of the founders and visiting lecturers to the MSc in Medical Technology Regulatory Affairs run by TOPRA and Cranfield University where she was also external examiner from 2009 to 2012.  Anne is also a course leader for Informa Connect since 2014.

Anne is also Vice-President of Team-PRRC, a non-profit organization set up in March 2020 to support individuals in the role of PRRC under the EU medical device regulations.

Mindy has multi-faceted medical device regulatory experience, having worked for a start-up, large global company and two notified bodies before joining Qserve, a medical device consulting company  Mindy’s hands-on experience as a development engineer, notified body auditor and technical file reviewer, global certification manager, and executive has led to a practical approach in developing and implementing regulatory, quality and clinical strategies and supporting documentation.

• Since 2000 President Medical Device Safety Service GmbH (MDSS) Founder MDSS Consulting and ITN Holding GmbH
• 1996-2000 Lead Auditor and Expert with leading Notified Body (TÜV Rheinland)
• 1997-2000 Manager of the San Diego TUV office
• 1995-1996 Research and Development of Medical Devices
• University degree (Dipl. Engineer), Aachen University of Technology
• Founding Member and Deputy Chair of the European Association of Authorized Representatives (EAAR)
• Member of the European Medical Device Coordination Group (MDCG) and the Commission Working Group on Vigilance
• Member of the Ethics Committee of the Medical Council (Aerztekammer) for Lower Saxony
• Member of the Regulatory Affairs Professional Society (RAPS) USA
• Founder and President of the RAPS Germany Chapter