Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global convergence of regulatory requirements and has been engaged in many international conferences, workshops and meetings with regulators from various emerging markets around the world over the last decade. Currently, she is the Vice Chair of the EFPIA IREG, member of EFPIA Middle East network and several IFPMA expert groups.

Ursula is the Head of Regulatory Affairs at Tigen Pharma, a clinical stage biotech company focused on cell-based cancer therapies. She has over 20 years of experience in Regulatory Affairs, Quality Assurance, Manufacturing and R&D thanks to global leadership roles in both large Pharma (Novartis, Boehringer Ingelheim) and small Biotech companies. She is a long time active member of several non-for profit organizations (namely DIA) and speaks four languages fluently. Ursula holds a PhD in cell and molecular biology and an MBA she earned with honors.

Sylvie has been engaged in regulatory policy activities for 20 years, through positions in Brussels trade associations, including EFPIA. She joined MSD as Director Global Regulatory Policy in June 2015, where she is now Global CMC Policy Director. Sylvie’s expertise and knowledge of the European pharmaceutical environment serves to drive regulatory policy activities in the areas of CMC and Quality in the EU and globally. Sylvie also co-leads the IFPMA Manufacturing & Quality Group policy activities. Sylvie holds a Maîtrise in Biochemistry from the University of Bordeaux II and a Diploma from the University of Kent at Canterbury.

Frank Montgomery was awarded his PhD in Synthetic Organic Chemistry at Imperial College London and completed Post Doctoral studies at Ohio State University. He then moved to Ciba Central Research in Discovery Chemistry then to AstraZeneca Process R&D. Frank led the Process R&D team for AstraZeneca’s project in the FDA’s CMC pilot program for implementation of ICH Q8, leading subsequent consultations with PMDA, EMA & Health Canada. Frank moved from a technical role to Regulatory Affairs and is now Global Head Regulatory CMC for small and large molecules across AstraZeneca/Medimmune. He is a member of ICH Expert Working Group as EFPIA Expert for ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.

Ben is the Global Head of CMC and Nonclinical Regulatory for GSK. After completing a Bachelor’s degree in Biochemistry at the University of Cardiff, he started his career in Quality Assurance supporting Drug Substance manufacturing. After several years in the manufacturing environment, Ben moved to a role in Regulatory Affairs and over the past 15 years has held leadership roles in pre-and post-licencing of Small Molecule, Biopharmaceutical and Cell & Gene Therapy product areas, prior to his current role of leading the CMC and Nonclinical Regulatory function.

Falk Ehmann is Head of the Innovation and Development Accelerator at the European Medicines Agency leading early stakeholder interactions on Innovation and Business Pipeline / Portfolio and Forecasting activities including Horizon Scanning. Falk Ehmann co-chairs the EU-Innovation Network driving EU pharma policy and strategy with current focus on the New Pharmaceutical Legislation. Falk Ehmann is a medical doctor with a PhD in Experimental Medicine and a degree in European and International law.

Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. He represents Amgen in EFPIA MQEG and represents EFPIA on GMPs/inspections, in ICH training and ICH-QDG and before on ICHQ9, ICH Q-IWG and ICHQ7-IWG. In PDA he was at the board and chaired RAQAB.

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.

Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team at the WHO's Headquarters in Geneva, Switzerland.

Seya Colloud is a pharmacist by training and holds a Masters in International Drug Regulatory affairs from University Paris-Sud, (France). She works as Global Regulatory Director in the personalized healthcare team for F. Hoffmann La Roche in Switzerland. Her area of expertise and interest include medicine and digital health regulations. She is particularly interested in the regulatory frameworks at the interface between software as medical device and medicinal product development, including novel outcomes to measure diseases.

Dr Stuart Finnie is a Regulatory Affairs professional with over 20 years of experience within the Pharmaceutical Industry. Working within the field of Chemistry, Manufacturing and Controls (CMC) he has developed experience of both synthetic and biological molecules from development through to life-cycle management. Currently, he is working as a director within AstraZeneca’s Regulatory CMC Group, focussing on the life-cycle management of their biological product portfolio.

Bjorg Hunter holds a BSc in Design and Innovation Engineering from Technical University of Denmark and an MSc in Biomedical Engineering from Aarhus University, Denmark. Bjorg started her career at GSK in 2010 where she has held positions with increased resistibility stating in the device development area both in R&D and Regulatory fields. In 2020 Bjorg took up a new position in NovoNordisk where she is leading the RA Device Combination Products department and in 2022 moved to a position as Director of RA Digital Health within RA CMC and Devices. Bjørg has also been very active in external advocacy, including driving industry positions on behalf of EFPIA.

Matt Popkin has a degree in Chemistry from the University of Bristol and a PhD from University College London. Following postdoctoral research, he joined GSK to work as synthetic chemist in 2000. Since then, he has worked in a number of roles in the CMC development and registration of novel medicines. In his current role he is responsible for CMC Policy, Devices and vaccines facilities. Matt is vice-chair of Manufacturing and Quality Expert Group of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Amongst his roles for EFPIA, he leads the CMC PRIME/COVID task force, has been a member of the ICH Q11 Implementation Working Group, and currently represents EFPIA on the ICH Quality Discussion Group.

Ragini Shivji is a pharmacist, with a Ph.D. from the University of Nottingham, UK. She worked for a number of years for the UK MHRA as a senior pharmaceutical assessor on a range of biotechnology / biological submissions. She has worked for the European Medicines Agency for nineteen years in the Quality Office, where her role as a principal quality specialist requires input into many aspects of biotechnology / biological applications with a focus on vaccines, particularly influenza and pandemic preparedness and currently COVID-19 vaccines.

Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing and personal data protection in health research on medicines. He joined the EMA Inspections Service in 1999, and became Head of Compliance and Inspections (2009) and Head of Division Inspections and Human Medicines Pharmacovigilance in 2013 (including Scientific Committee Services from 2016). He has a BA (Physiology 1979) a Dr de 3eme Cycle (cancer biology 1982), and PhD (Pharmacology 1986). Fergus worked in clinical research mainly in QA from 1982 to 1999.

Adam Walker is a Director in CMC Regulatory Affairs at GSK. After receiving a PhD in Cell Biology from the University of Cambridge, he joined Domantis Limited, a Biotechnology company based on human antibody fragment technology developed in the University Cambridge LMB, leading preclinical discovery programmes. Following the acquisition of Domantis by GSK, he led the microbial and mammalian fermentation and downstream purification functions in GSK’s Innovative Biopharmaceuticals Discovery Unit. After roles in GSK’s clinical development organisation Adam moved to a role in Global Regulatory Affairs, and has led the Cell and Gene Therapy function within CMC Regulatory Affairs since 2018.

Camelia Cercel is Global Head Regulatory CMC for Advanced Accelerator Applications (AAA), a Novartis company. Prior to joining AAA in 2015, Camelia hold different roles during 7 years within Regulatory Affairs in Medochemie Ltd., Cyprus, first as part of the RoW registration team and later as Product Manager, New Products Development. Before she held Regulatory Affairs Specialist roles supporting newly developed oncology drugs in Sindan-Pharma, an Actavis company based in Romania and previously for a local generics manufacturer supporting local registrations. Camelia holds a degree in Chemistry and a master degree in "Optimization of chemical-analytical control and quality assurance" from Faculty of Chemistry, Bucharest University.

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.

Evangelos is a Qualified Pharmacist and has got an MSc on Pharmaceutical Analysis and Quality Control from the University of Athens, Greece. He has joined the European Medicines Agency (EMA) in 2005. Currently he works as Quality Senior Specialist in the Quality of Medicines Office providing scientific support in the evaluation of new products, and in Scientific Advice requests. Evangelos is also involved in the work of the EMA Quality Working Party and Biologics Working Party and in the development of scientific guidelines. He has previously worked in Industry in R&D and gained experience in pharmaceutical development, manufacturing and quality control.

Daniela graduated in Biological Sciences from the University of Brasilia (2002) and completed her PhD in Molecular Biology in the University of Brasilia (2007). Specialization in Health Surveillance by FIOCRUZ, in 2010. Currently, Daniela is the specialist in health surveillance of the National Health Surveillance Agency (Anvisa), with the position of Deputy Director for Director Alex Campos, in the Third Board of Anvisa. She acted as Manager of Biological Products Office at Anvisa from 2014 to 2018.

Armin Ritzhaupt, is a scientific administrator at EMA providing regulatory support to development, evaluation and surveillance of medicinal products for human use. He provides regulatory support to the Innovation Task Force and leads on activities related to the implementation of the new medical device and in vitro diagnostic regulations. Armin worked in industry from 2002 to 2015 in different roles in clinical development and global regulatory affairs before joining EMA. He holds PhD in biochemistry from the University of Liverpool, and a Masters of Global Public Health from the University of Manchester. He completed a postdoctoral fellowship in virology at the Center for Biologics Evaluation and Research (CBER), FDA.

Dr Saint-Raymond is a French paediatrician. In 1995, she joined the French Medicines Agency, and in 2000 she joined the EMA where she was the Head of Special Areas (Paediatrics, Orphan Drugs, Scientific Advice, SME Office and Scientific Projects). She implemented the European Orphan Drug Regulation then the Paediatric Regulation. She has been an expert for the European Commission, the European Developing Countries Trial Partnership, the Canadian Council of Academies, and the US National Academies of Science, Engineering and Medicine, a member of the UN Commission on Life-Saving Commodities for women and Children and Associate Prof of Paediatrics at Tor Vergata University Rome.

Matthew is the Asst Health Attaché for US FDA's Europe Office, where he works to develop relationships and further FDA engagement with European stakeholders. Much of his time is devoted to supporting implementation of the US-EU Mutual Recognition Agreement for GMP Inspections, but his current portfolio covers all FDA-regulated commodities. He joined the FDA in 2007 in CDER's Division of Gastroenterology Products where he managed the review of new drug applications and worked with sponsors to facilitate new drug development. Prior to joining the FDA, he worked as a consultant to biotechnology, pharmaceutical and private equity clients. He has a degree in Molecular Biology from the University of Wisconsin and an MBA from Georgetown.

Dr. Gert Thurau leads Manufacturing Technology and Innovation Advocacy at Hoffmann-La Roche, Basel, Switzerland. He advocates for advanced technology adoption in GMP manufacturing, including continuous processing, process models, robotics, advanced analytical technology, but also the introduction of AI and Machine Learning methodologies in these areas. Recently, he represented EFPIA and Roche in EMA Quality Innovation Group sessions, participated in FDA workshops on innovative manufacturing approaches, and presented at the DIA Europe 2024 Diamond Session on Innovation in Manufacturing in Brussels.

Prior to joining AAA in 2018, Jordi served as Global Head of Supply Chain Quality Assurance for Novartis. Before this he was Head of Pharma Supply Chain Quality Assurance and Responsible Person for the Distribution licenses for Novartis Pharma AG and Novartis Pharma Services AG. From 2014 to 2015, Jordi held the position of Global Quality Process Lead for within the Novartis Pharma Quality organization and from 2010 to 2014, he was Global Quality Operations Manager for Products. Jordi first started his tenure at Novartis in 2005, as a Quality IT Manager at a manufacturing site in Spain and moved to Basel in 2009, to oversee the implementation of a Laboratory Information Management System at all Novartis Pharma manufacturing sites.

Diane Wilkinson was awarded her B.Pharm at Nottingham and PhD in Pharmaceutical biotechnology at Manchester UK Universities. A 35 year career in the Pharmaceutical Industry. A strong advocate for regulatory harmonisation, as well as the use of science, risk based CMC approaches and acceptance of these, to help bring accelerated access to medicines for global patients, Diane is a member of EFPIA biomanufacturing team, involved in 2018 workshop with EMA/FDA on CMC acceleration strategies. Diane is also a member of EFPIA IQDG, member of Vaccines Europe COVID CMC Team and is VE representative for CEPI COVID Manufacturing SWAT, collaborating with Gavi, WHO, Bill Gates Foundation, IFPMA and the CEPI Reg. Advisory Group.

Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team to successfully deliver its policy objectives and advocate for improved regulatory system strengthening. Prior to joining IFPMA, Janis worked in quality assurance and regulatory compliance for a US-based multinational company specializing in food service and retail. Janis holds a Master of Science in Communication-Public Relations and a Bachelor of Science in Agriculture-Food Science.

Alberto Ganan Jimenez is a Pharmacist and a Biochemist and holds a PhD on Molecular and Cell Biology from University of Zaragoza (Spain). After working in Pharmaceutical Industry in Business Intelligence positions, Alberto joined the EMA in 2006 as a Product Lead in the Quality of Medicines Office. In 2013, he was appointed Head of Procedures office and since 2022 he is leading the Committees and Quality Assurance Department. This department hosts the secretariat of the Scientific Committees and Working Parties and the Expert panels on Medical devices, provides quality assurance on regulatory and labelling aspects of medicines and is responsible for the procedural management of minor variations and validation of initial MAAs.

Stephanie Horn is an device expert in the Technical Regulatory group of ROCHE Pharma. A biologist by education she received her doctorate in virology from the University of Erlangen-Nuernberg, Germany. For over 20 years she is engaged in the in-vitro diagnostics and medical device industry in Europe and the US. She has strong skills in compliance and regulatory affairs for medical devices and drug-device combination products.

During over 10 years in the pharmaceutical industry, Susanne Kindermann has led multiple regulatory programs for small molecule drugs, peptides and oligonucleotides. She started her career in industry developing protein and peptide drugs for sustained release at a small biotech company, before entering the field of cmc regulatory affairs. Currently, Susanne is a team leader in cmc regulatory at Roche. She holds a Ph. D. in chemical biology from ETH in Lausanne, Switzerland. Susanne is a member of the European Pharma Oligonucleotide Consortium (EPOC).

Dr. Razhdzestvenski has over 16 years' experience in the Regulatory Affairs system. He has medical background and also graduated as a clinical pharmacologist. Starting as an assessor in the Belarus Center of Expertise and Testing in Health Service, he worked as a Head of Clinical Pharmacological Laboratory, Ministry of Health, Republic of Belarus till 2014. Since 2014 Dr. Razhdzestvenski is working at the Eurasian Economic Commission in the Division for Coordination of Common Market for Medicinal Products and Medical Devices Formation, which is coordinating activities on Common medicines market regulations development in Eurasian Economic Union.

Andrei Spinei is the Team Lead for manufacturing in the Inspection Office at EMA that deals with GMP inspections, quality defects and product recalls, sampling and testing and international collaborations on GMP and inspections. In his role Andrei works very closely with the GMDP Inspectors Working Group. He holds an MSc. in Pharmacy and before joining the European Medicines Agency he has worked for several years in regulatory affairs in the pharmaceutical industry.

Brian Dooley has worked as a quality specialist in the Pharmaceutical Quality Office of EMA since 2016, working mostly on centralised marketing authorisations and scientific advice, and supporting the development of scientific guidelines by the CHMP, QWP and BWP. From 2008 to 2016, Brian worked as a pharmaceutical assessor in the IMB/HPRA (Ireland). He holds a B.Sc. in Pharmacy (2005) and M.Sc. in Pharmaceutical Medicine (2015) both from Trinity College Dublin, Ireland. Areas of interest: lifecycle management, quality risk management, assessment-inspection interface, synthetic peptides, oligonucleotides, mRNA, sterilisation processes, radiopharmaceuticals.

Angelika Joos is a trained pharmacist. She is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional networks to define policy positions, and informing MSD’s regulatory strategy development. Angelika represents MSD in the IFPMA Regulatory Science Committee and is one of IFPMA's delegates to the ICH Management Committee. She is also involved in international policy activities though efpia as well as BIO and PhRMA international Committees. She served on the DIA Board of Directors from 2013-2020.

Laurence is a qualified pharmacist. He joined the Health Products Regulatory Authority in 2004 and worked as a quality assessor for almost 12 years before being appointed to his current role of Scientific Affairs Manager in April 2016. Laurence is actively involved in the implementation of a number of initiatives related to the HPRA’s strategic goal to support health product innovation, including the HPRA’s Innovation Office. He is also co-chair of the EU Innovation Network (EU-IN), which has a joint mandate from the European Medicines Agency and the Heads of Medicines Agencies.The EU-IN brings together representatives from innovation offices across the EU medicines regulatory network to facilitate the development of innovative medicines.

Abhishek Telang is a Senior Scientist in the Global Regulatory Affairs - Device and Drug-Device Combinations CMC group at Merck & Co., Inc. In his current role, he is responsible for driving global regulatory strategies for both developmental and marketed drug-device combination products. Abhishek holds a Ph.D. in Materials Science & Engineering from the University of Cincinnati and has 3 years of experience in the development and commercialization of Class II and III medical devices and combination products.

Rebecca is a Director in the Pfizer Global Regulatory Policy and Intelligence group. Focus areas include expedited and reliance approval pathways, regulatory system strengthening and evolving standards of evidence especially in International regions. Prior to joining Pfizer in 2017, she was Head of Science Policy at the UK Trade Association (ABPI) and has worked on numerous policy issues relevant to the biopharmaceutical industry during her 8 years there. She is a Co-Chair of the FIFARMA’s Regulatory and Biologics Working Group and a member of the Expedited Pathways group in EFPIA. She was a post-doctoral scientist prior to her career in policy, with a PhD from Fitzwilliam College, University of Cambridge (UK) in cell signalling.

Nevena Miletic is a pharmacist, with postgraduate studies in parmacoeconomics, Reg Affairs and QA, with more than 18 years of experience in pharma industry. Currently she works in Global Regulatory Policy at F. Hoffmann-La Roche and for the last five years, she is co-chairing IFPMA Africa Regulatory Network and CPP Network. She is also a member of IFPMA Regulatory Science and Africa Engagement Committees, DIA MEA Advisory Board, EFPIA ERAO PI WG, IATF etc., being involved in numerous projects with regulators and cross-industry collaborative platforms (e.g. Pre-ICDRA, ICDRA, IMI, SCoMRA etc.). Nevena is a strong advocate for regulatory convergence and harmonisation, with main interest in innovative approaches in drug development and review.

Acting Director for the Division of Inspection Assessment within OPQ/OPF. His division is primarily responsible for the center level discipline review of facilities and inspections in support of drug applications. He joined the Agency in November 2009 after graduating with his PharmD from the University of Maryland and his MBA from the University of Baltimore. Prior to FDA, he had experience in the generic pharmaceuticals industry. He continues to practice pharmacy in the community setting.