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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.


Speakers

  • 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
    • F. Hoffmann-La 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 over the last decade. Currently, she is the Vice Chair of the EFPIA IREG, Chair of the EFPIA Russia reg network, and member of EFPIA Middle East network and several IFPMA expert groups.

  • Sylvie  Meillerais, MSc

    Sylvie Meillerais, MSc

    • Director Global CMC Policy
    • Merck Sharp & Dohme (MSD Europe Inc.), 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. She is an active member of the EFPIA Manufacturing and Quality Experts Group and of the Middle East network, where she leads the Life Cycle Management efforts. She is further engaged in IFPMA CMC & Quality policy activities. Sylvie holds a Maîtrise in Biochemistry from the University of Bordeaux II.

  • 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 Pharmaceuticals LP, 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 7 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

  • Veronika  Jekerle, PhD, RPh

    Veronika Jekerle, PhD, RPh

    • Head of Pharmaceutical Quality
    • European Medicines Agency, Netherlands

    Veronika Jekerle joined the European Medicines Agency in 2006. She has been a Product Team Leader for numerous Biological medicinal products applications including Recombinant proteins, Vaccines, ATMPs and Biosimilar applications. In 2014 she became a Quality Specialist within the Specialised Scientific Disciplines Department where she provides specialised scientific input to various procedures including ITF, scientific advice, PRIME, marketing authorisation and post-marketing procedures. She has also coordinated the development of a number nt guidelines in the area of Advanced Therapies, Recombinant proteins and Biosimilars.

  • Lawrence X. Yu, PhD

    Lawrence X. Yu, PhD

    • Director, Office of New Drug Products
    • 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 is the General Manager of Medicines in the Brazilian Health Surveillance Agency - Anvisa. Before joining the Agency, he worked in development of new pharmaceutical products. Since joining Anvisa in 2007, he has worked in different position, such as General Manager of Ports, Airports and Land Borders, Manager of Public Quality Control Laboratories, Manager of Food Registration and General Manager of Inspectorate. He is graduated in Biochemistry and Pharmacy (University of São Paulo) and he has a master’s degree (University of São Paulo) and two graduate courses (Oswaldo Cruz Foundation and Federal Fluminense University).

  • 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

    • Manager, Radiopharmaceuticals and Monoclonal Antibodies Division
    • Health Canada, Canada

    Mr. Hamel spent his last 20 years working with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), where he is currently Division Manager of the Radiopharmaceuticals and Monoclonal Antibodies (Inflammation) Division. During his career 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.

  • Marie  Valentin, PharmD

    Marie Valentin, PharmD

    • Technical Officer, Regulatory Convergence & Networks Team [RCN], Regulation &
    • Safety Unit [REG], Regulation & Prequalification Dept, World Health Organization, Switzerland

    At WHO, Marie works in the Regulatory Convergence and Network Team towards convergence, harmonization, reliance and system strengthening activities, supporting different regional regulatory networks and supporting Member States to strengthen their regulatory systems, with a part. Before joining the WHO in May 2019, Marie worked for 8.5 years at the European Medicines Agency in London as a Regulatory Affairs Officer where she was in charge of providing regulatory and procedural advice in relation to the development, evaluation and surveillance of medicinal products in the European Union. Before that, she worked in the pharmaceutical industry, contract research organization and consultancies in the United Kingdom, Spain and France.

  • Rita  Algorri

    Rita Algorri

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

    Rita Algorri, PhD is a Manager, Regulatory Affairs CMC at Amgen Inc. in Thousand Oaks, CA. Rita serves within Amgen’s Advocacy and External Engagement function which fosters collaboration with multiple cross-functional teams to coordinate and progress company and industry initiatives. She has led and co-authored multiple peer-reviewed articles on topics such as structured content management, agile manufacturing, regulatory acceleration, and others. Rita is also the Product Team Lead for the CMC Data Exchange platform currently under development by Accumulus Synergy. She 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

    Mümün Gencoglu

    • 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

    • Senior Scientific and Policy Advisor (Acting), OPF, 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 in Regulatory Technology expert groups. He is a member of the Accumulus Consortium Leadership Team and co-chairs its EU subcommittee. 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, PhD

    Gert Thurau, PhD

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

    Gert spent the early part of his career in the development and registration of new CMC technologies like RTRT, feedback control or MVDA process modeling. Subsequently he lead the CMC Reg department at Roche for clinical and launch registration of SM molecules With launches of 5 new products in 6 years this also included regulatory innovations like the application of the ICH Q12 guideline in submissions and other science-based lifecycle management tools. His current role is the advocacy lead for implementation of manufacturing technology innovation as part of the Roche/Genentech Reg CMC Policy team.

  • 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.

  • 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

  • Al Awadh  Saeed

    Al Awadh Saeed

    • Expert
    • Saudi Food and Drug Authority, Saudi Arabia

    Dr. Al Awadh is Expert in Saudi Food Drug Authority, he worked in the Regulatory Affairs and Products Quality Evaluation for more than 12 years. He hold his PhD in Pharmaceutics form King Saud University and he is currently a member of Pharmaceutical Quality Knowledge Management System in ICMRA.

  • 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

    • Director, International Global Regulatory Affairs & Scientific Policy
    • Merck KGaA, Switzerland

    Isabelle has joined Merck Serono since 2005 where she has held growing managerial roles in RA and RA CMC as Head of Department. She is actively engaged in international regulatory policy as member of IFPMA Biotherapeutics WG and IFPMA Regulatory Strategy Committee since 2015. She takes part in several initiatives and sub-teams including EFPIA IREG LCM WG, and ICH Q12. 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

    • Director, CMC Strategy
    • GlaxoSmithKline, United Kingdom

    Matt Popkin achieved a degree in Chemistry from the University of Bristol & 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 several roles in the CMC development and registration of novel medicines. Currently Director, CMC Strategy and Advocacy for CMC Regulatory Affairs. Matt represents GSK on the Manufacturing & Quality Expert Group of EFPIA, where he was a member of the ICH Q11 Implementation Working Group, who developed the Q&A on API Stating Materials completed in 2017. Since its inception in 2019, he has represented EFPIA on the new ICH Informal Quality Discussion Group.

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