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.

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.

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.

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.

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.

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.

Alastair has worked in various roles in pharmaceutical product development, before moving into regulatory publishing at a major clinical research organisation. He then headed the International Regulatory Operations function at SmithKline Beecham and GSK, and as Director of Publishing, he led the UK based publishing team, working on the implementation of eCTD in the company. Alastair is now Director, Submission Standards at GSK, responsible for ensuring that GSK’s strategy with respect to electronic submissions and IDMP is aligned with external requirements. He is a member of the EFPIA IDMP Sub Group and active on several European projects, such as eAF and DADI. Alastair has a BSc (Hons) in Applied Chemistry from Aston University in B'ham.

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.

Marianne Ashford is a Senior Principal Scientist in a global role in Advanced Drug Delivery Department within Pharmaceutical Sciences at AstraZeneca. Marianne is responsible for applying drug delivery approaches to enable the progression of innovative medicines and is working to enable novel targets through targeting and intracellular delivery. She has been instrumental in introducing nanomedicines to into the Oncology portfolio and the building of the internal capability in nanomedicines/delivery science. Marianne holds Honorary Professorships at the Universities of Nottingham and Manchester and is a Fellow of the Controlled Release Society. She serves on Editorial Boards of Journal Pharmaceutical Sciences & Journal Controlled Release.

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.

Mr. Hamel spent his last 23 years working with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada as Senior Evaluator and Division Manager. He is currently Associate Director with BRDD. Mr. Hamel was involved with reviewing the CMC information pertaining to CTAs, NDSs and Post-Marketing changes associated with Biotherapeutics and represented Health Canada on the WHO drafting group in charge of developing the WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products. Mr. Hamel is also a member of the ICH M4Q EWG and ICH Q12 IWG and leads its implementation in Canada. He is pleased to share his experience with the ICH Q12 pilot program in Canada.

Torsten Kneuss studied Business Administration and Engineering. Since 1999 he has been working with pharmaceutical packaging materials, medical devices and combination products, including several years within the field of quality control, development, operations, and pharmacovigilance. Since October 2020 he is, as a Quality Product Steward Medical Devices and Head of Project Office Medical Devices, responsible for devices and combination products within Bayer AG.

Dr. Lee is currently Deputy Super Office Director for Operations who oversees research, quality surveillance, policy, quality assurance, and administrative operation functions in CDER’s Office of Pharmaceutical Quality. Dr. Lee has been with the FDA since 2005, serving as a regulatory scientist, team lead, Associate Director for Science, Deputy Office Director, Office Director, and Deputy Super Office Director of Science. He has provided exemplary leadership in developing OPQ science, research and testing programs to support quality assessment, inspection, surveillance, and policy.

Regulatory Affairs Expert at Saudi_FDA with a demonstrated history of working in the pharmaceutical industry . Member of ISO Committees. Skilled in Pharmaceutics, Pharmacovigilance, Healthcare, Clinical Research, and Regulatory Affairs. Strong quality assurance professional with a Master's degree focused in Pharmaceutical Sciences from King Saud University.

Sean is a Senior Biologicals Assessor at the Irish health authority, HPRA, where he reviews CMC data for new product applications, scientific advices, clinical trials, and variations for mAbs, recombinant proteins, vaccines, and cell & gene therapies. Sean is chair of the Biologicals Working Party (BWP) at EMA and regulatory chair the ICH Quality Discussion Group. He has helped draft several guidelines such as the EMA toolbox guidance for PRIME products, the EMA reflection paper on statistical methodology, and the EMA-FDA Q&A on regulatory flexibilities. As a member of the ICMRA collaborative assessment group, Sean helped establish the first pilot programme for multi-agency assessment of post-approval CMC changes.

Dr. Christopher Downey is the Director of the Division of Pharmaceutical Manufacturing Assessment VI in CDER/OPQ’s Office of Pharmaceutical Manufacturing Assessment (OPMA), a role he has held since May 2022. His division ensures product quality and sterility for CDER-regulated biologics by assessing microbiology controls and manufacturing data in BLAs, and leading pre-license inspections (PLIs) of manufacturing facilities. Previously, Dr. Downey was a Review Chief (2017–2022), Team Lead (2014–2017), and Reviewer (2012–2014) in the Office of Biotechnology Products. He holds a PhD in Biochemistry from the University of Colorado at Boulder and was a postdoctoral fellow at the University of Colorado and Georgetown University Medical Center.

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.

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.

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.

Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He was the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission initiatives, including the Pharmaceutical Quality/Chemistry, Manufacturing, and Controls structured data project. He is also serves as a delegate to the International Organization for Standardization's (ISO) Technical Committee (TC 215) on health informatics which deals with the IDMP standards. Currently he is Associate Director in FDA’s Office of Process and Facilities in CDER. He has never served time in prison.

Christian Wetter is an organic chemist and holds a Ph.D. from the University of Marburg. He started his professional career at Roche in 2004 in Chemical Development before moving to Novartis to Regulatory CMC in 2009. In 2020 he joined Roche again and currently acts as a Senior Regulatory Portfolio Director. Christian has worked on small molecule, peptide, oligonucleotide and device development projects in various phases of development and commercial lifecycle. He is part of the European Pharma Oligonucleotide Consortium (EPOC) and is currently leading its regulatory subteam.

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.

Connie Langer is a Senior Director at Pfizer who leads a team that monitors and advises on regulatory changes and impacts. She collaborates with experts to communicate Pfizer's feedback and position to health authorities on regulations and guidance documents. She also has experience implementing science- and risk-based approaches and recommending strategic regulatory options to achieve product approvals globally. She is a member of the ISPE PQLI® ICH Q12 Working Team and chair of the IQ ICH Q12 Working Group. She holds BS in Chemical Engineering and an MS in Chemical Oceanography both from the University of Connecticut, and a Drug Development Certificate from Temple University.

Dr. Wassim Nashabeh is the Vice President and Global Head of Regulatory Policy & International Operations for the Roche Pharmaceutical Group. In this capacity, Wassim has oversight of all technical outreach activities with global health authorities, industry associations and scientific organizations. Wassim is a member of the ICH Management Committee and Assembly since 2018 and has been a member of several ICH Expert Groups including Q3D, Q11 and Q12 on behalf of BIO.

Rodrigo Palacios is an Executive Director in Regulatory Policy at Roche. He is responsible for advancing global policy on data and technology in the regulatory domain. These topics include Cloud Submissions, Data Standardisation (e.g. IDMP), structured data submissions, eCTD and Regulatory Information Management. Rodrigo represents Roche in EFPIA and PhRMA Regulatory Technology expert groups and acts as PhRMA's deputy topic lead in the ICH M4Q R2 Expert Working Group. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.

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.

Dr. Joel Welch is the Deputy Office Director for the Office of Product Quality Assessment III in the Office of Pharmaceutical Quality at CDER, FDA. His office assesses product quality for small molecule APIs and biological products (excluding microbiology). He serves as the Rapporteur for the ICH revision to Q5A(R1) and Chair for the Emerging Technology Program. Previously, Dr. Welch was Associate Director for Science & Biosimilar Strategy, focusing on policy and emerging issues in the biosimilar program. He has held roles as Review Chief, Team Leader, Primary Assessor, and Regulatory Project Manager. Prior to FDA, he worked in industry for six years on late-stage analytical development of small molecules

Michael Abernathy, Executive Director, leads Amgen’s Global RA CMC function. The extent of Michael’s responsibilities traverses molecular discovery, early and late-stage clinical development and approved life-cycle programs. He also founded Amgen’s RA CMC External Engagement function targeting activities that comprise a CMC focus, promoting company and industry initiatives, engaging with Health Authorities around the world and contributing to industry organizations. In 2020, Michael was selected to the non-profit Accumulus Synergy Executive Leadership Team as the CMC Use Case Lead, focused on transforming the filing and review of CMC content into an automated and cloud-based eco-system.

As Director of EU Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities. Simon started at Biogen in 2003 in the clinical group before moving into Regulatory Sciences and undertaking increasingly senior roles across regulatory product development and lifecycle management. He has been working in regulatory policy since early 2016. Prior to joining Biogen, Simon worked in medical communications in different therapeutic areas. He is a biologist by training with an MSc in medical parasitology.

Manager of Office for Quality Evaluation of Small Molecules (GQMED/GGMED) since october/2019. Previously manager of Office for Quality Evaluation for Registration of Small Molecules. Also acted as deputy General Manager of General Office for Small Molecules and Biologics in 2018 and assistant for Registration Directory at ANIVSA. Previus experience in analytical method development and validation, especially degradation products, and API manufacturers representation to brazillian pharmaceutical companies.

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.

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.

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.

Mr. Abdullah H. AL-Hatareshah is a Clinical pharmacist; He is appointed as the Executive Director for Regulatory Affairs at the Saudi Food and Drug Authority (SFDA). Prior to this, Mr. AL-Hatareshah was the Director of the Product Licensing Department and Director of the Clinical Trial Department. Mr. AL-Hatareshah is active member with ICH, he started as a member of ICH expert working group (E17 EWG) since 2014 and now he is ICH Assembly member and IPRP committee member. He was a member of the National Committee of Bio Ethics. Mr. AL-Hatareshah has diversified experience in clinical trial regulation, evaluation, and drug regulatory affairs processes.

Dr. Mohammed Aldosari is a scientific assessment expert of biological medicinal products at Saudi FDA (Saudi Arabia) since 2008. Mohammed is a pharmacist by education and gained the master degree in biotechnology from Macquarie University (Australia) and doctoral degree in biopharmaceutical biotechnology from Utrecht University (Netherlands). He has been involved in the development of investigational biological drugs (Novel/Biosimilar). Mohammed has over 10 years of regulatory experience in CMC assessment for different biological medicinal products such as monoclonal antibodies, recombinant hormones/enzymes, vaccines and biosimilars. He published several scientific papers related to development and regulation of biological orphan drugs.

Dr. Ibrahim Algayadh is a Senior Expert in Drug Evaluation and Regulation at SFDA and he is registered and licensed as a Consultant Pharmacist at Saudi Commission for Health Specialties. He is a member of ICH S5 (R3). He obtained his PhD in Pharmaceutical Sciences with specialization in Pharmacology and Toxicology from the University of Louisiana, USA in 2017, having obtained his Master degree in Toxicology from the University of Birmingham in 2009 and his Bachelors from the School of Pharmacy, King Saud University. He has had a number of scientific articles published in peer-reviewed journals. Since joining the SFDA, he has been involved in several scientific evaluation, strategic projects, consultations, SOPs, guidelines and regulations.

Isabelle has joined Merck KGaA since 2005 where she has held growing managerial roles in RA and RA CMC as Head of Department. She currently is Head of International Global Regulatory & Scientific policy at Merck and as such actively engaged in international regulatory policy as member of IFPMA since 2014, representative at ICH TrSC, EFPIA and PhRMA ICH WG. Prior to joining Merck, she has worked for several Companies in areas of small and large molecules including in Clinical Development for Servier Laboratories, and assumed various manufacturing site managerial responsibilities within Sanofi GMP QA & RA. Isabelle holds a MSc and a Pharm. D from Lyon (France) coupled with an MBA from Paris (EAP) High Business School.

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, assessment-inspection interface, synthetic peptides, oligonucleotides, mRNA technology, sterilisation processes, radiopharmaceuticals.

Mr. Yahya I. Al-Nujaym is the Director for the Standards Directorate at the Saudi Food & Drug Authority. Prior to this, Mr. Al-Nujaym was in the Quality Assurance for Drug Sector at SFDA for four years. In addition to his previous experiences in projects and strategic planning, Mr. Yahya has worked with WHO on several projects related to guidelines and standards. Mr. Al-Nujaym holds a Masters degree in Business Administration from Thompson Rivers University Kamloops, BC Canada and a Post-baccalaureate Diploma in Marketing from the same university. Mr. Al-Nujaym holds a Bachelors degree in Pharmaceutical Sciences from King Saud University, Saudi Arabia.

Currently the Scientific Evaluation Specialist II at the Executive Directorate of Product Quality Evaluation (Variations and Re-Registration Department of the Saudi Food and Drug Authority.

Dr. Bonelli is the ICH Management Committee representative for the European Medicines Agency, where he works as Scientific Advice Officer. He is a Doctor in Medicine (Univ. of Rome) specialised in clinical pharmacology and has published various articles accounting for his professional research activities. This was mostly in the area of molecular oncology and stem cells, focused on the use of patient-derived tumor samples for the development of drug screening assays. Since joining the EMA in 2011 and before moving to his current role, he has worked in (and led) the non-clinical and clinical pharmacology support office providing scientific analyses and support for initial MAs and Scientific Advice procedures.