Tufts Center for the Study of Drug Development – ACG Professional Certificate in Clinical Pharmacology, Drug Development and Regulation

The Tufts Center for the Study of Drug Development (Tufts CSDD) is excited to collaborate with The American College of Greece to offer an online version of its highly acclaimed Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation. This new 2-week, intensive, live-interactive program offers a Professional Certificate in Clinical Pharmacology, Drug Development and Regulation from the Deree – School of Graduate and Professional Education. The Tufts CSDD-ACG program provides advanced instruction in practical and technical problem-solving in the areas of clinical pharmacology, drug development & clinical trial strategies, biopharmaceutical development, drug safety and new drug regulation. Top lecturers from academia, industry, and government will share their insights and expertise to create a stimulating learning environment.

When: March 11 – March 24, 2021 (8 meetings), EST 10:00-14:00 / GR 17:00-21:00

Where: online (live-interactive) via Zoom

Language of Instruction: English

Audience: By registration only

Overview

This intensive course will examine the important economic, political, legal, and scientific issues that affect the development of new medical products, including drugs, biologics, vaccines, medical devices, and in vitro diagnostics. Lectures by academic and industry experts will cover a broad range of topics, including the regulation of drugs and biologics, the clinical development process, translational pharmacology, the development of vaccines and devices, drug safety and pharmacovigilance, pharmaceutical marketing, the role of social media in patient engagement, the regulation of drug advertising, the reimbursement environment, chemistry manufacturing and controls (CMC), as well as strategic alliances in drug development, especially with respect to COVID-19.

Who is this for?

Individuals involved in the discovery, development, manufacturing, regulation, marketing, and financing of pharmaceutical and biopharmaceutical products. These include drug industry professionals, clinical investigators, regulators, academic scientists, consultants, healthcare professionals, and investors.

Prerequisites

Undergraduate degree in Biology, Pharmacy, or Health-Related Discipline.

Why attend?

The Professional Certificate in Clinical Pharmacology, Drug Development and Regulation is designed to provide participants with a broad and comprehensive understanding of issues related to the development and regulation of drugs, biologics, vaccines, devices, and in vitro diagnostics. Lectures focus on basic drug development topics – such as translational medicine, clinical pharmacology, epidemiology, drug regulation, and adverse drug event reporting – as well as broader topics – such as pharmacoeconomics, drug-device combinations, biosimilars, working with investigative sites, and drug marketing.

Learning Outcomes

At the end of the course, participants should be able to engage in:

  • The economic, legal, political, and scientific issues affecting the development of new medical products.
  • The development process for drugs, biologics, vaccines, and devices covering translational pharmacology, clinical development, regulatory review, manufacturing, post-approval research, and pharmacovigilance.
  • Drug and biologic regulation in the United States, the EU, and elsewhere, and the impact of current regulatory policies and initiatives on medical product development.
  • Efforts to meet the needs of special populations, including drugs for rare diseases, pediatric populations, and neglected diseases.
  • Reimbursement, economic assessments, and access to new medical products.
  • Pharmaceutical marketing and its regulation, as well as the role of social media in patient engagement.
  • The roles of the various stakeholders in the innovation landscape and the opportunities and challenges of strategic partnership models.

Delivery Mode

The course will be delivered online, using the Zoom platform.

To participate online, you will need the following:

  • a laptop or a desktop computer (handheld devices lack certain functionalities so are unsuitable)
  • a broadband speed wired Internet connection
  • earphones or a headset
  • a microphone (standalone or built into the earphones or headset)
  • a webcam
  • Zoom (it is free and will be downloaded onto your computer as soon as you click on the link you will receive from us)

Dates & times

Thursday, March 11, 2021 | EST 10:00-14:00 / GR 17:00-21:00

Tuesday, March 16, 2021 | EST 9:00-14:00 / GR 16:00-21:00

Wednesday, March 17, 2021 | EST 10:00-14:00 / GR 17:00-21:00

Thursday, March 18, 2021 | EST 10:00-14:00 / GR 17:00-21:00

Friday, March 19, 2021 | EST 10:00-14:00 / GR 17:00-21:00

Monday, March 22, 2021 | EST 10:00-14:00 / GR 17:00-21:00

Tuesday, March 23, 2021 | EST 10:00-14:00 / GR 17:00-21:00

Wednesday, March 24, 2021 | EST 10:00-14:00 / GR 17:00-21:00

To download the detailed schedule please click here.

Course fees

Regular single participant fee: €2000

In order to register a deposit of 400 Euros within 5 working days is required. The remaining amount of 1,600 Euros is payable in full by March 2021. Please contact us for a payment plan.

Corporate discounts for groups

Group of 3-4   10% discount
Group of 5-10 15% discount
Group of 11+  20% discount

Cancellation policy

Participants may cancel their registration and receive a full tuition refund by March 8, 2021. We will not be able to refund cancellations received after March 8, 2021.

Non-endorsement statement

The content and views presented in this educational activity are those of the faculty and do not necessarily reflect the opinions or recommendations of Tufts University School of Medicine or Tufts Center for the Study of Drug Development. Inclusion in this activity does not constitute approval or endorsement of any commercial products or services. These materials have been prepared based on the best available information, but are not exhaustive of the subject matter. Participants are advised to critically appraise the information presented and encouraged to consult the available literature for any commercial products mentioned. 

About the Tufts Center for the Study of Drug Development

The Tufts Center for the Study of Drug Development, located in Boston, Massachusetts, helps drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops and public forums. 

Instructors

Varvara (Barbara) Baroutsou MD, PhD

Global Fellow in Medicines Development

Dr. Baroutsou studied in Greece, Sweden and France. She is a licensed Physician Certified in Internal Medicine. She graduated from the Medical School of University of Athens in 1984. Following a scholarship in Respiratory Pathophysiology at the Experimental Respiratory Lab of the University of Athens where she completed her PhD, she completed her residency in Internal Medicine at the “Amalia Fleming” General Hospital in Athens. She then served as registrar and clinical investigator acquiring experience in clinical research at the “Sotiria” General Hospital of Thoracic Diseases. After a positive Phase III pivotal clinical trial collaboration, in 1992 she joined Merck Research Laboratories and worked in Clinical Development responsible for Clinical Research in the Middle Europe Region until 2004. During this period, she pursued postgraduate studies in Health Economics at the Stockholm School of Economics in 1998 & and later on moving to Sanofi, as Regional Medical & Scientific Director, she acquired a European Market Access Diploma from the University Claude Bernard Lyon 1 in 2012. In January 2015, she joined Novartis as Chief Scientific Officer in Greece and in June 2016 she was promoted to Chief Scientific Officer for Medical Affairs and Clinical Development in Western Europe until the end of June 2020. Currently, she is an Independent Medical Consultant and Pharmaceutical Medicine Consultant affiliated with Greek Medical Schools’ postgraduate programs on Infectious Diseases, Molecular Basis of Human Diseases and Clinical Pharmacology Therapeutics. Dr. Baroutsou is the President of the Hellenic Pharmaceutical Medicine Society-ELEFI, a Member of the Ethics, External Affairs and Communication Groups of the International Federation of Associations of Pharmaceutical Medicine (IFAPP). In October 2019, she hosted the joint IFAPP& IFAPP Academy Regional meeting for Europe. In November 2019, she  was selected as Global Fellow in Medicines Development. In July 2020, she was invited to join the European Forum for Good Clinical Practice (EFGCP) forum as Member of Core Faculty. Her major interest is in collaborating with academia, experts, clinical investigators, patient associations and regulators putting patient-centered R&D and innovation in health care agenda for patients’ better outcomes. She is a strong believer of the expanded value proposition of Pharmaceutical Medicine, as discipline bridging Research & Development with practice of Medicine and patient access to optimal care.

Paul Beninger, MD, MBA

Associate Professor of Public Health and Community Medicine at TUSM, Director of the MD/MBA and MBS/MBA Programs at Tufts University School of Medicine

Dr. Beninger began his career in drug development in 1987 at the US Food and Drug Administration, first as a reviewer and manager for drugs against HIV/AIDS and opportunistic infections, and then as a division director for medical devices. He joined Merck & Company in 1995 and developed experience in regulatory affairs, medical affairs and drug safety in the areas of anti-infective drug and biological products, vaccines, anti-diabetic drug products and oncology drug products, before joining Genzyme as vice-president of pharmacovigilance in 2006; Genzyme was acquired by Sanofi in 2011. Dr. Beninger retired from Genzyme-Sanofi in April 2017. Dr. Beninger trained in internal medicine and infectious diseases. He received his MD from the University of California, Davis, his BA from Claremont McKenna College in Claremont, California, his MBA from St Joseph’s University in Philadelphia, Pennsylvania, and his graduate certificate in epidemiology from Tufts. He has published and spoken extensively on regulatory science, drug and vaccine safety, and pharmacovigilance, and he is a fellow of the American College of Physicians and the Infectious Disease Society of America.

Jerry M. Collins, PhD

Associate Director of Developmental Therapeutics, Division of Cancer Treatment and Diagnosis, National Cancer Institute, U.S. National Institutes of Health

Dr. Collins received his Ph.D. from the University of Pennsylvania and completed a postdoctoral fellowship at Johns Hopkins University School of Medicine. He spent a total of 11 years at the National Institutes of Health, including 5 years as Chief of the Pharmacokinetics Section at the National Cancer Institute. In 1988, Dr. Collins joined the U.S. Food and Drug Administration, where he directed the Clinical Pharmacology Lab for 17 years. In 2005, he returned to NIH to lead the Developmental Therapeutics Program at the National Cancer Institute. His 200 publications have emphasized PK/PD principles in Oncology, especially for first-in-human studies.

Michael A. Egan, PhD

Chief Scientific Officer and Vice President of R&D

Dr. Egan brings to Auro Vaccines 25+ years of vaccine research experience. Prior to joining Auro Vaccines, Dr. Egan. served as a Project Leader within the Translational Discovery Group at the Gates Medical Research Institute. Previously, Dr. Egan lead a diverse team of scientists in the conception, design and execution of various vaccine discovery programs as a Senior Director at Takeda Vaccines. In addition, Dr. Egan was the Director of Immunology at Profectus Bioscience from 2008-2017 and served in various roles at Wyeth Vaccines Research from 2000 – 2008. Dr. Egan received his Ph.D. in Immunology from the Johns Hopkins University School of Medicine and went on to do his postdoctoral training at Harvard Medical School. Dr. Egan has served on numerous NIH scientific review committees and has 40+ publications to his credit in the area of vaccine research and development.

Janet E.A. Forrester, PhD

Associate Professor, Department of Public Health and Community Medicine at Tufts University School of Medicine

Janet Forrester holds a PhD from McGill University in Epidemiology and Biostatistics. She currently holds a position as an Associate Professor in the Department of Public Health & Community Medicine at the Tufts University School of Medicine, where she is the Associate Director of the Doctorate in Public Health degree program and directs courses in epidemiology and biostatistics. Over that past 20 years, she has conducted epidemiologic studies, including randomized trials, in the area of infectious diseases and nutrition. Her current research is focused on the role of microbiota on the nutritional status of children.

Kenneth A. Getz, MBA

Professor at Tufts University School of Medicine, Deputy Director of Tufts Center for the Study of Drug Development

Mr. Getz conducts research focusing on drug development management strategies and tactics; protocol design practices; and global outsourcing, investigative site and patient recruitment practices and policies. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Mr. Getz has published extensively in peer-review journals, books and in the trade press and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials. He holds a number of board appointments in the private and public sectors, including WCG and ORA, and serves on the editorial boards of Pharmaceutical Medicine and TherapeuticInnovation and Regulatory Science. Mr. Getz received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Mr. Getz is the founder of CenterWatch, a leading publisher in the clinical trials industry.

Joseph D. Gormley

Director of Advanced Systems Development/Cognitive Computing, Tufts Clinical and Translational Science Institute (CTSI), Tufts University and Tufts Medical Center

Mr. Gormley has over twenty-five years of science and engineering experience within Fortune 100 pharmaceutical and chemical corporations, Top 10 academic and medical institutions and early-stage biotechnology companies. Degreed in both Computer Science and Molecular Biology his career has spanned multiple life science domains including rational chemical design, biomarker discovery, drug development and clinical analytics. As the Director of Advanced Systems Development and Cognitive Computing at the Tufts Clinical and Translation Science Institute (CTSI) he leads multiple full-stack AI-based software development initiatives including a next generation machine learning platform for automated drug discovery and repurposing. He is a past recipient of a John Adams Innovation Award to assess commercialization strategies for Computational Systems Biology. He is a current recipient and Co-Principal Investigator on multiple NIH Biomedical Translator awards to develop intelligent knowledgebase technologies for clinical and translational research. Mr. Gormley received his BS in computer science from the University of Maryland and an ALM (Master in Liberal Studies) in molecular biology from Harvard University.

Alberto Grignolo, PhD

Corporate Vice President, Global Strategy and Services, Parexel Consulting

Alberto Grignolo is a Corporate Vice President at PAREXEL Consulting with over 37 years of experience as a regulatory and drug development professional and corporate executive; including 27 years as a consultant to pharmaceutical and biotechnology companies and driver of a successful worldwide regulatory and drug development consulting business. He established the firm’s Japan Consulting Services during a two-year assignment in Tokyo. He is the Executive Sponsor of drug development programs on behalf of selected clients of PAREXEL. He participates actively in PAREXEL’s Diversity and Inclusion initiatives and in corporate efforts to promote and maintain a High-Performance Culture and excellent customer service. Dr. Grignolo is a past Chairman of the Board of the Regulatory Affairs Professionals Society (RAPS), has been involved in the advancement of the regulatory profession for most of his career, and was the recipient of the 1995 Richard E. Greco Professional of the Year Award from RAPS. He has been an active member of the Drug Information Association (DIA) since 1984, served on the DIA Board from 2000 until 2004, was the Chair of the 2007 DIA Annual Meeting and has been an Instructor on the DIA Regulatory Training Faculty for nearly two decades, teaching in the U.S., Europe, Australia, Japan, Korea and China. He was a Member (2008-2011) of the first Executive Committee of the Clinical Trials Transformation Initiative (CTTI), a Public Private Partnership between the FDA and Duke University aiming to increase the quality and efficiency of clinical trials. He was an Expert Adviser to the Institute of Medicine’s “Committee on Assessing the System for Protecting Human Research Participants” in 2000-2002, received the 2008 Lifetime Achievement Award from the GCP Journal, and was recognized as one of the 100 Most Inspiring People in the Life-Sciences Industry in 2008 by the readers of PharmaVOICE. Prior to joining PAREXEL, Dr. Grignolo served as President of FIDIA Pharmaceutical Corporation and held regulatory positions at SmithKline & French Laboratories. After his undergraduate degree at Duke University, he earned a doctorate in Experimental Psychology from the University of North Carolina and conducted postdoctoral research in neuropharmacology at Duke University Medical Center. A native European who has also lived in Latin America and Japan and speaks four languages, Dr. Grignolo has been a frequent Speaker, Program Chair, Session Chair or Instructor at more than 120 international conferences, seminars, workshops and courses on Drug Development and Regulatory Affairs and has published more than 60 professional and scientific articles. He is the Editor-in-Chief of DIA Global Forum magazine, received DIA Global Inspire Award (Global Connector) in 2015 and was named a Fellow of DIA in 2017.

Kenneth I Kaitin, PhD

Professor of Public Health and Medicine at Tufts University School of Medicine, Director of Tufts Center for the Study of Drug Development

Dr. Kaitin has served as Director of the Tufts Center for the Study of Drug Development since 1997, and he is a Professor of Public Health and of Medicine at Tufts University School of Medicine. He is also an Advisory Professor at Shanghai Medical College at Fudan University in China, and he serves on the faculty of the European Center for Pharmaceutical Medicine at the University of Basel. An internationally recognized expert in drug development science and policy, Dr. Kaitin writes, speaks, and teaches on global trends in pharmaceutical development and regulation, and he has provided public testimony before the U.S. Congress on drug development issues. A former President of the Drug Information Association, Dr. Kaitin is currently Editor-in-Chief of Expert Review of Clinical Pharmacology, and he is a consultant to the U.S. Department of Defense on bioterror countermeasures. In 2011, he received the Dr. Louis M. Sherwood Award, granted by the Academy of Pharmaceutical Physicians and Investigators, and in 2020 he was named a Global Fellow in Medicines Development by the International Federation of Pharmaceutical Physicians. Dr. Kaitin serves on several public and private life science company boards of directors. He received his BS from Cornell University and MS and PhD in pharmacology from the University of Rochester.

Susan Kornetsky, MPH

Senior Director of Clinical Research Compliance, Boston Children’s Hospital, Boston, MA

Ms. Kornetsky is Senior Director of Clinical Research Compliance at Boston Children’s Hospital. She has a Masters of Public Health and completed a Medical Ethics Fellowship at Harvard Medical School. She is past Chair of Board for the organization Public Responsibility in Medicine and Research (PRIMR) and served on the board for 16 years. She is a past member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) and was co-chair of the Sub-committee on Children and served on the Subpart A subcommittee. She is a past Board member of the Association for the Accreditation of Human Research Programs (AAHRP), and past site visitor. She was a member of the Institute of Medicine’s Committee on Clinical Research Involving Children. She was on the Council for Certification of IRB Professionals (CCIP) and served as a Council co-chair. She is faculty for Harvard Medical School Global Education and lectures at national and international meetings, most recently teaching clinical research ethics in London, Turkey and Portugal. She is a consultant for (OPRR) site visit teams. She lectures on research ethics and IRB regulations for Harvard Medical School courses on research ethics. She is a member and Consulting Advisor for the leadership committee of AEREO a consortium of leaders in institutional human subjects research oversight, who aim to improve the effectiveness of Institutional Review Boards (IRBs) through empirical methods. Topics of interest include pediatric research, boundaries between research and innovation, biobanking and the obligation to return research results to subjects.

Robert A. Morgan, MS, JD

Senior Vice President, Development Operations, Verastem Oncology

Robert Morgan has been involved in drug development for over 30 years with experience in both large and small pharmaceutical companies covering every aspect of drug research and post-approval market development. He has a graduate degree in Medical Physics and is an attorney licensed in Massachusetts. Currently Mr. Morgan is Senior Vice President Development Operations at Verastem Oncology, a biotech oncology company developing novel therapeutics hematologic cancers and solid tumors. Verastem recently launched it first commercial product, a PI3K inhibitor targeting CLL/SLL and FL. During his career Mr. Morgan has submitted and maintained multiple IND, NDA, Orphan Drug and International regulatory filings and has been the team leader for multinational clinical studies. He also filed the first electronic IND application accepted by the FDA, using the international standard Common Technical Document format. He has held positions of increasing responsibility in medical research and has lead teams in the development/clinical/regulatory/quality areas for both large and small companies such as Samus Therapeutics, MediVector, Ziopharm Genzyme, Serono, EPIX Pharmaceuticals and DuPont/DuPont Merck.

Chandrasekhar Natarajan, BPharm, MSc, MS

Chief Scientific Officer, ViNa Pharma Consulting, Adjunct faculty, Tufts University School of Medicine

Mr. Chandrasekhar (Nat) Natarajan is the Chief Scientific Officer at ViNa Pharma Consulting, LLC. He is also an Adjunct Faculty at Tufts School of Medicine. Earlier at Sanofi as an Associate Vice President in Drug Disposition division and a Strategic Scientific Advisor, supported Oncology programs providing critical input on translational pharmacology, ADME and PK/PD in discovery and development. Nat received his B. Pharm and his MSc in Pharmacology from the University of Madras, India. His MS in Pharmacotherapeutics was from Long Island University, New York and his clinical pharmacy training was at Downstate Medical Center in New York. Nat has had years of experience in different areas of research at different levels at Boehringer Ingelheim, Bristol Myers Squibb and Aventis. He was the Deputy Global Head of Discovery MPK providing Discovery Support at Sanofi-Aventis overseeing effective chemical optimization and druggability of new compounds for desirable ADME & pharmacokinetic properties. Nat is an invited speaker (faculty) at, The Harvard Clinical and Translational Science Center, Boston, MA, and Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA. He has given presentations on Translational medicine at CSIR-Institute of Genomics & Integrative Biology (CSIR-IGIB), Mathura Road, New Delhi 110020, India., Gulf Medical University, Ajman, United Arab Emirates., Cancer Drug Discovery & Preclinical Development. Active Communications International, London, UK., Society for the Study of Xenobiotics-India, Bangalore, (SSX-India), and PERI, Biologics and Biosimilars, An Integrated Overview of Product Development, Fairfax, VA. Nat is an active member of AAPS, ACCP, SITC and DIA.

Jerald S. Schindler, DrPH

Vice President, Biostatistics, Alkermes, Inc., and Adjunct Professor, Biostatistics, Harvard T.H. Chan School of Public Health

Dr. Schindler is Vice President, Biostatistics at Alkermes Pharmaceuticals. He leads the group that is responsible for the statistical design and analysis of all clinical trials at Alkermes. Earlier, Dr. Schindler served in various leadership roles at Merck Research Laboratories including Vice President, Global Late Development Statistics. This global group of 140 statisticians was responsible for the design and analysis of clinical trials for all therapeutics areas under development at Merck. They participated in more than 30 successful regulatory submissions for novel drugs around the world. Dr. Schindler has also led the adoption of adaptive trial design and decision making at Merck which has led to dramatic efficiencies in terms of cost and time. Dr. Schindler is also Adjunct Professor of Biostatistics at the Harvard T.H. Chan School of Public Health and is on the faculty of the Post Graduate Course in Pharmacology at the Tufts University Center for the Study of Drug Development. Prior to joining Merck, Dr Schindler was President of the Pharmaceutical Research Division at Cytel. And earlier he was the Chief Biostatistician and Global Head of Biostatistics and Clinical Technology at Wyeth Research, where he led 120 staff in the quantitative science groups responsible for drug development. Dr. Schindler received undergraduate and master’s degrees from Georgetown University and a doctorate in Biostatistics from the University of North Carolina, Chapel Hill.

Richard Shader, MD

Professor Emeritus of Immunology and Psychiatry at Tufts University School of Medicine

A 1956 graduate of Harvard College, Dr. Shader received his medical degree from the New York University School of Medicine in 1960. He received his psychiatric training at the Massachusetts Mental Health Center at Harvard Medical School and at the NIMH in Bethesda, Maryland. He also graduated from the Boston Psychoanalytic Institute where he was a Joseph Michels merit scholar. Prior to joining the TUSM faculty, he was on the faculty at Harvard Medical School where he achieved the rank of Associate Professor. He is a former chairman of both the Department of Pharmacology and Experimental Therapeutics and the Department of Psychiatry at Tufts. Dr. Shader also served as Program Director for graduate studies in the Program in Pharmacology & Experimental Therapeutics at the Tufts School of Biomedical Sciences. He is also a Medical Consultant at the Tufts Center for the Study of Drug Development. In addition to being a former MERIT Investigator of the National Institutes of Health (NIH), Dr. Shader was also a member of the National Advisory Mental Health Council appointed by President Ronald Reagan. He was a member of the Scientific Advisory Board for the NIMH Hypericum Trial and of the Advisory Board for the NIMH Research Units in Pediatric Psychopharmacology. He served on the overall Data Safety Monitoring Board (DSMB) for the NIH Center for Complementary and Alternative Medicine, as well as on the DSMB for its Silymarin trials. He currently chairs the DSMB for COMPASSPathway’s Psilocybin for Depression trial. Dr. Shader was the President of the American College of Neuropsychoharmacology (ACNP), the American Board of Psychiatry and Neurology, and the American Association of Chairmen of Departments of Psychiatry. He is a former Director and member of the Executive Committee of the American Board of Emergency Medicine and still serves as a Senior Director. Dr. Shader was an individual winner of the American Psychiatric Association’s Seymour Vestermark Award for Psychiatric Education. He received it a second time with colleagues from the ACNP. He has been a member of the Scientific Advisory Board of the Alzheimer’s Foundation and the Association for Aging Research. During the academic year 1990-1991, he was the Kaiser Family Fellow at the Center for Advanced Studies in the Behavioral Sciences in Stanford, CA. He is Editor-in-Chief (E-i-C) of the Journal of Clinical Psychopharmacology and was also the E-i-C of the journal Clinical Therapeutics from 2012 until 2019. In addition, he is the author or co-author of over 950 scientific publications and the author, editor, or co-editor of 21 scientific books and monographs. According to ResearchGate, as of December 2019 his publications have received over 24,500 citations in peer-reviewed journals and his h-index is 83.

Theoharis C. Theoharides, MS, MPhil, PhD, MD, FAAAAI

Professor of Pharmacology and Internal Medicine; Director of Molecular Immunopharmacology and Drug Discovery, Department of Immunology at Tufts University School of Medicine; Director of Health Science Programs and Research for The American College of Greece-Deree

Born in Thessaloniki, Greece, Dr. Theoharides graduated with Honors from Anatolia College. He received all his degrees from Yale University (BA, cum laude in Biology and History of Medicine, MS, MPhil, PhD, MD), and was awarded the Dean’s Research Award and the Winternitz Price in Pathology. He trained in internal medicine at New England Medical Center, which awarded him the Oliver Smith Award recognizing excellence, compassion and service.” He also received a Certificate in Global Leadership from the Tufts Fletcher School of Law and Diplomacy and a Fellowship at the Harvard Kennedy School of Government. He has been serving as the Clinical Pharmacologist of the Massachusetts Drug Formulary Commission continuously since 1986. In Greece, he served on the Supreme Advisory Health Councils of the Ministry of Health and of the Ministry of Social Welfare, as well as on the Board of Directors of the Institute of Pharmaceutical Research and Technology where he established the Laboratory of Drug Equivalency.. He Chaired an International Committee appointed by the Hellenic Ministries of Education and Health for the establishment of an independent medical school in Greece, and he is a member of the International Advisory Committee for the University of Cyprus School of Medicine. He is also the President of Biomedical Consulting and Development Co, Inc. (MA, USA), President of BiomedAdvice, LLC (MA, USA) and Scientific Director of Algonot, LLC (FL, USA). He is a member of 15 academies and scientific societies. He was inducted into the Alpha Omega Alpha National Medical Honor Society and the Rare Diseases Hall of Fame.  He has received the Tufts Excellence in Teaching ten times, the Tufts Distinguished Faculty Recognition Award twice, the Tufts Alumni Award for Faculty Excellence, Boston Mayor’s Community Award, and the Dr. George Papanicolau Award. He has also been awarded an Honorary Doctor of Medicine from Athens University and an Honorary Doctor of Sciences from Hellenic-American University, as well as the 2018 Albert Nelson Marquis Lifetime Achievement Award and the 2018 Distinguished Humanitarian Award (Marquis Who is Who).  He is an “Archon” of the Ecumenical Patriarchate of Constantinople.

George Vassilopoulos, DPharm, PhD

Managing Director, Galenica, SA Greece

Dr. Vassilopoulos represents Greece in the IMI States Representatives Group since June 2014. He is an Executive Consultant of the Hellenic Union of Pharmaceutical Industry, which represents the local Pharmaceutical Manufacturers that in their vast majority are SMEs, with own or outsourcing R&D infrastructures and activities. He has 30 years of experience in managing Pharmaceutical and Social Security Organizations. He is also an invited Lecturer to Post-Graduate Study Programs in Athens and Patras Universities in the fields of Management and Pharmacoeconomics.

Elias Zintzaras, MSc, PhD

Professor of Biometry and Laboratory of Biomathematics at University of Thessaly School of Medicine, Greece

In addition to his position at the University of Thessaly School of Medicine, Dr. Zintaras is an Adjunct Professor at the Institute for Clinical Research and Health Policy Studies, and the Pharmacology & Drug Development Program at Tufts University School of Medicine. Dr. Zintzaras is the  of CEO and Scientific Coordinator of BECRO, Inc., a Greek company conducting clinical trials, therapeutic equivalence studies, bioequivalence studies, regulatory affairs, data management and biometrics, monitoring, pharmaceutical market research & advisory boards.


For more information, please email [email protected] or call +30 210 600 9800 ext. 1532, 1332.

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