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.

Helen Fitton was awarded her PhD in Synthetic Organic Chemistry at University of Newcastle Upon Tyne UK before moving to the Wellcome Foundation to assume a regulatory affairs role. Within GSK and its former companies, she has held multiple roles within the Regulatory Affairs function including the Global Head of CMC and Nonclinical Regulatory for small and large molecules and Cell and Gene Therapy and Head Regional Regulatory, before recently becoming Head Global Regulatory Affairs (Pharma). Helen co-lead the company wide team for ICH Q12 which drove the cross company internal position and external engagement plans. She has been engaged in multiple CMC agency consultations and a former member of the BIA Regulatory Affairs Subteam.

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.

Graduate of Jordan University of Science & Technology received her Master’s in pharmaceutical QA/QC from JUST. Worked as Regulatory affairs at Jordan Pharmaceutical manufacturing Company. In 2011 joined JFDA where she is now the head of the new & biological drugs division at registration department/drug directorate. She is currently a member of technical committee responsible for evaluation & Registration of originator drugs & Biological products. Head of PAC committee, responsible for evaluation & Approving PAC registered originator products. Responsible for the fast track registration project at JFDA. Today she is a pioneer in evaluation of registration files of medicinal products following the international Guidelines.

Dr Abigail Moran is a UK registered pharmacist and the Leading Senior Pharmaceutical Assessor at the MHRA, where she has been an assessor for nearly 16 years. Abigail is currently involved in the assessment of the quality aspects of new marketing authorisation and variation applications, in the team dealing with the therapeutic areas of oncology and musculoskeletal disease. She is a member of MHRA’s cross-agency Drug Device Combination Working Group, the UK member of CHMP’s Quality Working Party and Rapporteur for the European QWP/BWP drafting group for the guideline on the quality requirements for drug-device combinations.

Fabian Schwarb is a group leader in Global CMC Regulatory Affairs, Small Molecule Development Products at F. Hoffmann-La Roche Ltd in Basel/Switzerland. He is a Senior CMC regulatory affairs professional with over 20 years of industry experience in drug development and global registration of Clinical Trials, Marketing Authorization Applications, and Product Life Cycle Management. He obtained his Ph.D. in pharmaceutical sciences from the University of Basel.

Marta Antunes is currently a Senior Specialist in International CMC Regulatory Affairs EU/EMEA region at MSD. She has a Master’s Degree in Pharmaceutical Science and a Post-Graduate Degree in Regulation and Evaluation of Medicines in Health Products from the University of Lisbon. She is currently studying an MBA at Imperial College London. Marta worked in regulatory affairs and quality assurance areas before embarking on her regulatory CMC career. She has managed CMC pre and post approval activities and implemented CMC regulatory strategies for EU/EMEA countries. She has engaged with health authorities on brand new manufacturing technologies. Marta is a registered pharmacist by the Portuguese Pharmaceutical Council.

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.

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.

Giovanna Rizzetto is Senior Manager for the Regulatory, Drug Development and Manufacturing team and ICH Coordinator at EFPIA. She is responsible for the coordination of the Pharmacovigilance and Preclinical Development WGs. She previously held a position as a project manager where she was responsible for the management of international pharma-academic clinical trials. Giovanna has also worked in other Brussels industry trade associations and prior to that as an analytical chemist in different companies. She holds a Master's degree in industrial chemistry from the University of Venice (Italy) / University of Warwick (UK).

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.

T.G. Venkateshwaran (TG) currently serves as an associate vice president - Chemistry, Manufacturing & Controls Biologics and Combination Products, GRACS,Merck. TG joined Merck in November 2015 and has 18 years of pharmaceutical industry experience in R&D, quality, regulatory and manufacturing roles. TG has a Ph.D. in pharmaceutical sciences from the University of Georgia, and a B.S.(Honors) degree in pharmacy from the Birla Institute of Technology and Science in Pilani, India.

Mrs Hélène Bruguera graduated in Biochemistry from the University of Nancy and has a Master in Industrial Pharmacy from the University of Strasbourg. She worked for the pharmaceutical industry for 10 years in analytical development and in the preparation of the quality part for marketing applications. She joined the EDQM in year 2000, and is currently the Head of the Certification Department. She deals with the management of CEP applications as well as the EDQM inspection programme for API manufacturers. She is also involved in international platforms related to the quality of medicines and active pharmaceutical ingredients (ICH, IPRP), and is currently co-chair of the IPRP Quality Working Group for Generics (QWGG).

Veronika Jekerle hold the position as Head of Office for EMA’s Pharmaceutical Quality Office in the Human medicines Division at European Medicines Agency. The office manages pharmaceutical quality aspects for all human medicines across the lifecycle from early development to post-authorisation. A pharmacist by training, she joined European Medicines Agency in 2006 as a Product Team Leader for Recombinant proteins, Vaccines, ATMPs and Biosimilar applications. She held various positions including Quality Specialist and Scientific secretary for the Biologics working party and coordinated several guidelines in the area of Biologicals, ATMPs and vaccines as well as PRIME toolbox guidance and prior knowledge.

Dr. Moreira graduated as a pharmacist and holds Master & Doctoral degrees in biochemistry from Federal University of Rio de Janeiro. He joined Anvisa in 2007, where he served as CMC reviewer and also carried out GMP inspection of biological products. Currently, he's Advisor to Anvisa Director Dr. Alessandra Soares.

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.

Dr Vanhooren has more than 25 years of experience in the pharmaceutical industry covering regulatory, manufacturing and quality areas. Globally responsible for Chemistry Manufacturing Control (CMC), her portfolio touches the complete product life cycle, from IND /IMPDs for First-in-Human clinical studies, NDA / MAA applications through commercial product maintenance. She has extensive experience in drug development programs with novel technologies such as continuous manufacturing processes. Recently she has been responsible for the successful registration of several oncology products with simultaneous filings in US and EU. Dr Vanhooren earned her Ph.D. in organic synthesis of carbohydrate structures at the University of Hamburg, Germany.

Has been Quality Manager QMT MHS since Jan 2019 and will be Product Specialist for Art. 117 starting Dec 1st, 2019. She is re-joining TÜV SÜD Product Service GmbH – since previously an auditor within the department of active medical devices. Stephanie has gained more than 10 years of experience in various positions within the medical device & pharmaceutical industry: as development engineer in the field of bioresorbable implants and as quality manager in the field of in-vitro diagnostic devices & drug-device combination products. Stephanie studied medical engineering at the Technical University Munich, at the University of Applied Sciences Ulm and the University of Bradford; She holds a diploma engineering degree in medical engineering.

Oliver Grosche is analytical scientist by training and has worked in the development of new human and veterinary medicines for more than 18 years. In various roles, he has been responsible for the analytical development, QC, QA or Pharmacopoeial Compliance of APIs and Drug Products. Oliver Grosche has been a long-standing member of the efpia analytical lifecyle expert group since 2009. Recently he has been nominated as efpia representative to support the revision of ICHQ2 and the new issue of ICH Q14.

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.

Chantal Walther, Head Regulatory Assessment Unit 4 at Swissmedic (Swiss Agency for Therapeutic Products) holds a Master in Pharmaceutical Science (MSc) from the University of Basel. She worked in pharmacies for four years and joined Swissmedic in 2011 as Regulatory Manager in Unit 2. In 2020 she was promoted to Head Regulatory Assessment Unit 4. She deals with submissions for new- and known active substances in the oncologic field and since 2015 she is involved in international platforms (ORBIS, Access).

Christof joined Roche, working in as a team leader in biotechnology analytics in Switzerland and worked in several positions with increasing responsibilities. As Site Head Analytical Development Biochemistry he was responsible for the establishment of new analytical technologies, protein characterization, development and validation of analytical methods, quality control of investigational medicinal products and transfer of analytics to the commercial QC units. Besides the profound knowledge in the field of analytics Christof is an expert for QbD for product and process development and led the Roche QbD initiative. In his current position, Christof acts as a technical advisor within Roche’s biotech development and is a member the biotech dev