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Hotel Ilunion Alcora Sevilla

Sep 27, 2022 8:30 AM - Sep 28, 2022 3:00 PM

San Juan de Aznalfarache, 41920 Sevilla, Spain

Accelerating CMC Workshop

This Workshop will focus on the currently most relevant topics in the CMC (Chemistry, Manufacturing and Controls) regulatory space with a global perspective.


Ben  Thompson

Ben Thompson

Vice President, CMC and Non-clinical Regulatory Affairs, GlaxoSmithKline, United Kingdom

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, PhD

Frank Montgomery, PhD

Global Head Regulatory CMC, GRAPSQA, AstraZeneca, United Kingdom

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, PhD

Susanne Ausborn, PhD

Global Head International Regulatory Policy, Roche, Switzerland

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  Meillerais, MSc

Sylvie Meillerais, MSc

Director Global CMC Policy, MSD Belgium, Belgium

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.

Sara  Torgal, MPharm

Sara Torgal, MPharm

Senior Manager, Scientific Programs, DIA, Switzerland

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.

Dolca  Rogers

Dolca Rogers

Quality Specialist, Pharmaceutical Quality Office, European Medicines Agency , Netherlands

Dr. Rogers works in the Pharmaceutical Quality Office at the EMA. Before joing the Agenecy, she worked in research and development of new pharmaceutical products, from small molecules, antibodies to cell products. She also has experience in Regulatory Affairs in the pharmaceutical industry and as a consultant. Since joining the EMA in 2018 she has worked in the Pharmaceutical Quality Office providing scientific support for initial Marketing Authorisation, Variations and Scientific Advice procedures as well as input in support initiatives of the EMA with a special focus on ATMPS. She has a Master’s Degree (University of Barcelona) and a PhD in Chemsitry (Queen Mary University of London).

Gregory  Rullo, MS

Gregory Rullo, MS

Senior Director, Regulatory Affairs - CMC, AstraZeneca , United States

Greg Rullo has a wide range of experience in the strategic and tactical aspects of pharmaceutical drug development and global regulatory cmc knowledge. This regulatory knowledge/experience includes CMC specific knowledge of requirements in Latin American countries with a detailed understanding of submission requirements in Brazil. He has direct experience with Health Authorities meetings throughout the world including: FDA, EU health authorities, ANVISA and Chinese authorities. He was AstraZeneca’s Global Program Director for the integration and implementation of AstraZeneca’s sole regulatory document management, regulatory publishing and submission tracking systems.

Kowid  Ho, PharmD

Kowid Ho, PharmD

Pharma Technical Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland

Kowid Ho has been working at F. Hoffmann-La Roche Ltd.’s Global Pharma Technical (CMC) Regulatory Policy in Basel, Switzerland for >10 years. He was previously a quality assessor for biological products at Agence nationale de sécurité du médicament et des produits santé (ANSM, formely AFSSaPS) for 13 years. He has authored many European assessment reports and scientific advices on biotech, vaccines, blood and advanced therapy products, and has participated to several product related inspections. He was a member of European Medicines Agency (EMA) Biologics Working Party (BWP), Biosimilar Working Party (BMWP), and PAT/QbD team.

Henrik K.  Nielsen, PhD, MBA, MSc

Henrik K. Nielsen, PhD, MBA, MSc

Vice President, Novo Nordisk A/S, Denmark

Henrik K. Nielsen has a background as M.Sc. Chemical Engineering, Ph.D. in Biochemistry and MBA. He joined Novo Nordisk in 1983 and has held several positions in Research, Product Development and Manufacturing in Denmark and the USA. Since 2004 he has served in several leadership positions in regulatory affairs and is currently Vice President for Global Regulatory Sciences. He represents Novo Nordisk as regulatory and biotechnology expert in a number of trade associations such as PhRMA, IFPMA and EFPIA where he is chair of the International Regulatory Expert Group.

Victoria  Palmi-Reig

Victoria Palmi-Reig

International Affairs, European Medicines Agency, Netherlands

Victoria Palmi, Senior International Affairs officer, has over 20 years of experience at the European Medicines Agency (EMA). She supports international collaboration programs and reliance as part of her role in the International Affairs office. Previously, Victoria worked as Product Lead in different therapeutic areas within the Evaluation of Medicines department. During this time, she led initiatives that accelerated assessment and early access to priority medications.

Veronika  Jekerle, PhD, RPh

Veronika Jekerle, PhD, RPh

Head of Pharmaceutical Quality, European Medicines Agency, Netherlands

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.

Lawrence  Yu, PhD

Lawrence Yu, PhD

Director, Office of New Drug Products, OPQ, CDER, FDA, United States

Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food and Drug Administration and Rapporteur, ICH M4Q(R2) Expert Working Group. Dr. Yu is also an adjunct Professor at the University of Michigan. Dr. Yu is an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 150 papers and given over 400 invited presentations. He is a co-editor of the books entitled “Biopharmaceutics Applications in Drug Development”, “FDA Bioequivalence Standards”, and “Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, 2nd Ed.”

Nélio Cézar  de Aquino, MSc

Nélio Cézar de Aquino, MSc

General Manager of Medicines, ANVISA, Brazil

Nélio Cézar de Aquino is the General Manager of Medicines at the Brazilian Health Regulatory Agency (Anvisa). He has held various positions at Anvisa, including General Manager of Information Technology, Ports, Airports, Borders, and Customs Warehouses, Public Quality Control Laboratories, Food Registration, and GMP Inspection. He started his career at Anvisa in 2007 as an Inspector of Good Manufacturing Practices. Aquino holds a Bachelor's degree in Pharmacy and Biochemistry and a Master's degree in Pharmaceutical Sciences from the University of São Paulo. He also has specializations in Health Surveillance from the Oswaldo Cruz Foundation and in Micropolitics of Management and Work in Health from the Federal University of Fluminense.

Talia  Flanagan, PhD

Talia Flanagan, PhD

, UCB, United Kingdom

Talia is Associate Principal Scientist in Biopharmaceutics in AstraZenecas Product Development group. She has extensive experience of developing biopharmaceutics and clinically relevant dissolution strategies in development and post-approval settings. Talia is EFPIA Deputy Topic Lead on the ICH M9 Expert Working Group. She has been an invited speaker at several international conferences/workshops in the field of biopharmaceutics, and has authored/co-authored 18 manuscripts and one book chapter.

Hugo  Hamel, MBA, MSc

Hugo Hamel, MBA, MSc

Associate Director, BRDD, Health Canada, Canada

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.

Marie  Valentin, PharmD

Marie Valentin, PharmD

Team Lead, Facilitated Product Introduction, WHO, Switzerland

At WHO, Marie works as the Team lead for the Facilitated Product Introduction Team supporting the Member States by implementing various approaches and mechanisms, including collaborative procedures, reliance approaches, and joint activities at the national, regional, and international level to facilitate and accelerate the introduction of priority medical products in countries. Before joining the WHO in May 2019, Marie worked for 9 years at the European Medicines Agency in London as a Regulatory Affairs Officer. Before that, she worked in the pharmaceutical industry, contract research organization and consultancies in the United Kingdom, Spain and France.

Rita  Algorri, PhD, MS

Rita Algorri, PhD, MS

Senior Manager, Global Regulatory Affairs (CMC), Amgen, United States

Rita Algorri, PhD is a Senior Manager, Regulatory Affairs CMC at Amgen Inc. in Thousand Oaks, CA. In this role, her responsibilities include leading and orchestrating internal and external engagement activities relating to regulatory modernization, digitization, automation, and emerging technologies. She also serves within Amgen’s Advocacy and External Engagement function which fosters collaboration with multiple internal and external cross-functional teams to coordinate and progress company and industry initiatives. Rita is a microbiologist by training and holds a PhD in Clinical and Experimental Therapeutics and M.S. in Regulatory Science from the University of Southern California.

Hanan  Amin Rizk Hamoda

Hanan Amin Rizk Hamoda

Head of Centeral adminstration of Pharmaceutical Products, Egyptian Drug Authority, Egypt

-Professor of Pharmacology and Toxicology. -Head of Central Administration of Pharmaceutical Products - Egyptian Drug Authority (EDA). -Former head of general directorate of registration - Ministry of Health (MOH). -Former head of registration department - National Organization of Drug Control and Research (NODCAR). -Head of Technical Committee for Drug Control - Egyptian Drug Authority (EDA). -National communication point with UN agencies for Tech Access Partnership in joint effort to scale up local production of life-saving health technologies for COVID-19. -Contributed in issuing of Egyptian Herbal Monograph, EDA. -Former member in CTD committee - NODCAR. -Focal Point of Egyptian Drug Authority Associate Membership in ICMRA.

Myriam  Archambault, MBA, MSc

Myriam Archambault, MBA, MSc

Senior Regulatory Advisor, Office of Regulatory Intelligence and Risk Management, Health Canada, Canada

Myriam works as a Senior Regulatory Advisor at Health Canada where she coordinates International Work Sharing activities under the Australia-Canada-Singapore-Switzerland-United Kingdom Consortium (Access) and acts as a focal point for coordination of parallel reviews under Project Orbis (a US FDA lead initiative) with the FDA and other regulatory partners.

Mümün  Gencoglu, PMP

Mümün Gencoglu, PMP

Regulatory Affairs Manager, IFPMA, Switzerland

Tycho  Heimbach

Tycho Heimbach

Sterile & Specialty Products Group, Merck &Co. (MSD), United States

Dr. Heimbach is a Director at Merck in the Biopharmaceutics & Biologics Specialty Products Group where he serves as a biopharmaceutics and PBBM/PBPK expert in oral and parenteral drug development. Prior to that Tycho was at Novartis where he led a global PBPK modeling group in DMPK and served as PBPK/PBBM and biopharmaceutics expert. He served on the working groups for the PBPK renal and hepatic impairment WG and the PBBM WG for the Innovation and Quality in Pharmaceutical Development (IQ) consortium. In 2021 Tycho was recognized as a AAPS Fellow and he is an author/co-author of more than 60 publications in ADME, PBPK and formulation sciences.

Mahesh R. Ramanadham, PharmD, MBA

Mahesh R. Ramanadham, PharmD, MBA

Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER , FDA, United States

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.

Joel  Welch, PhD

Joel Welch, PhD

Associate Director for Science and Biosimilar Strategy, OBP, OPQ, CDER , FDA, United States

Joel Welch is the Associate Director for Science& Biosimilar Strategy in the Office of Biotechnology Products in the Office of Pharmaceutical Quality at the US Food and Drug Administration. He is responsible for assessing emerging, complex, or precedent-setting issues impacting science policies of the office with particular emphasis on the biosimilar program. He also serves as the Rapporteur for the ICH revision to Q5A(R1) and the Vice Chair for the Emerging Technology Program. In his time at FDA, he has also served as a Review Chief, Team Leader, Primary Assessor and Regulatory Project Manager. Prior to joining FDA, he spent 6 years in industry supporting late state analytical development of small molecules.

Amina  Al Haj Hussein

Amina Al Haj Hussein

Regulatory Affairs Specialist, Jordan Food and Drug Administration (JFDA), Jordan

Thierry  Gastineau, PharmD

Thierry Gastineau, PharmD

Global Head Quality Innovation, Culture & Engagement, Sanofi , France

Thierry Gastineau is Global Quality Head of Innovation, Culture and Engagement at SANOFI vaccines. He has 35 years of experience in the Pharmaceutical Industry, mainly in World Wide Regulatory Affairs and Quality activities. He is a member of multiple associations and working groups, in particular the following ones: • Vaccines Europe: Co-leader of CMC/Quality Core Team and LCM working group • IFPMA: Leader of the Vaccines Head of Quality group and of the working group on Post Approval Changes • Leader of the CMC/GMDP Covid-19 joint Vaccines Europe / IFPMA Task Force By education, he is Pharmacist and he holds a post graduate in molecular biology

Rodrigo  Palacios, MBA

Rodrigo Palacios, MBA

Regulatory Policy Lead, F. Hoffmann-La Roche, Switzerland

Rodrigo Palacios is an Associate 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. He has over 25 years of experience in data and technology strategy, Information Technology management, software development and consulting.

Joel  Raymond

Joel Raymond

Manager, Health Canada, Canada

Gert  Thurau, DrSc, PhD

Gert Thurau, DrSc, PhD

Head of Manufacturing Technology Innovation in CMC Regulatory Policy, F. Hoffmann-La Roche Ltd., Switzerland

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, and AI. Recently, he represented EFPIA and Roche in EMA Quality Innovation Group sessions, participated in FDA workshops on innovative manufacturing approaches, and spoke on AI's life cycle management at FDA PQRI workshops in 2023.

Mijeong  Kim

Mijeong Kim

Director- Pharmaceutical Standardization Division, NIFDS, MFDS, Korea, Republic of

Mijeong has over 30 years of experience in regulatory review, research & development, regulatory policy and regulatory compliance in the field of pharmaceuticals and medical devices, where she is currently a Director of the Pharmaceutical Standardization Division in the Drug Evaluation Department. In her role as a director, she is responsible for CMC assessment of drug products and is an active participant in global harmonization as a member of ICH Quality Discussion Group and IPRP Quality Working Group. She has a PhD in medicinal chemistry (Chung-buk Uni., Korea) and post-doctoral research experience in pharmaceutics (Trinity College Dublin, Ireland).

Dirk  Leutner, PhD

Dirk Leutner, PhD

, EDQM/Council of Europe, France

Dirk Leutner is head of the Pharmaceutical Technology Division in the European Pharmacopoeia Department of the EDQM. He is pharmacist with a PhD in Pharmaceutical Technology and experience in pharmaceutical industry in development of generics and as head of production. In 2013, he joined the EDQM as scientific program manager and worked for groups of experts in the field of medicinal product monographs, chemical substances, spectroscopic methods including PAT and the European Paediatric Formulary. Since 2017 he manages the work on excipients, dosage form monographs and testing, packaging material, PAT and the European Paediatric Formulary. He further coordinates the pharmacopoeial harmonisation (e.g. PDG) activities within the EDQM.

Saeed  Al Awadh

Saeed Al Awadh

Expert, Saudi Food and Drug Authority, Saudi Arabia

Dr. Al Awadh is Acting Director of Innovative Medicines in Saudi Food Drug Authority. He has worked in a number of roles in the Regulatory Affairs and Products Quality Evaluation for more than 12 years. Dr. Al Awadh hold his PhD in Pharmaceutics and he has many researchers focused on Novel drug delivery system, Nanotechnology, Cell based delivery system and Drug Targeting to cancer cell. In addition, he is a member of Pharmaceutical Quality Knowledge Management System in ICMRA.

Llorente  Bonaga, PhD

Llorente Bonaga, PhD

Director, Regulatory Affairs, CMC, Merck & Co. USA, United States

Dr. Llorente Bonaga is an experienced Regulatory Affairs CMC professional and is currently a Director in RA CMC at Merck Sharp & Dohme. He presently leads a team supporting global clinical studies and registrations of the company’s small molecule clinical candidates for various therapeutic areas. He has held Regulatory CMC positions in several small to large global companies, such as Genentech/Roche, ALZA, Vertex, Fibrogen, and Ultragenyx. He is involved with the IQ Working group on Co-Processed API. He started his industry career in Drug Discovery at the J&J PRD after a post-doctoral work at The Scripps Research Institute. He holds a Ph.D. in Organic Chemistry from the Florida State U and B.S. from U of the Philippines Los Banos.

Christof  Finkler, DrSc

Christof Finkler, DrSc

Senior Technical Advisor Biotech Development, F. Hoffmann-La Roche AG, Switzerland

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

Danny  Verkooij

Danny Verkooij

Associate Principal Scientist, Site CMC, Merck Sharp & Dohme, Netherlands

Danny Verkooij has more than 25 years of history in pharmaceutical industry. He started his career in in 1994 with MSD Haarlem within QA and switched to the role of Internal Project Coordinator in New Products Planning in 2002. He left MSD in 2005 to join a consultancy company in The Netherlands, Xendo. In this company he was part of the team who offered RA support for both small molecules and biologicals, including vaccines and blood products. In 2011 he joined the Haarlem site of Teva as a Regulatory Affairs Officer and became head of site RA and member of the Site Leadership Team in 2018. In 2020 returned to MSD in the role of Associate Principal Scientist, Site CMC.

Isabelle  Colmagne-Poulard, PharmD, MBA, MSc

Isabelle Colmagne-Poulard, PharmD, MBA, MSc

Head, International Global Regulatory & Scientific Policy, Merck, Switzerland

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.

Amy  Keegan

Amy Keegan

, MSD, United States

Christian  Wetter, PhD

Christian Wetter, PhD

Technical Regulatory Advisor, Roche, Switzerland

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. Since 2020 he has been a Regulatory Advisor in Small Molecule Development at Roche. 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.

Mike H Saleh, MS

Mike H Saleh, MS

Director, Global Chemistry, Manufacturing and Controls, Pfizer, Inc., United States

Matt  Popkin, PhD

Matt Popkin, PhD

Senior Director, CMC Excellence, Global Regulatory Affairs, GSK, United Kingdom

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.

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