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-===== DIA Global =====
-{{::dia_network.png?600|}}
-For more than 50 years, DIA (the Drug Information Association) has served as a global forum for all those involved in health care product development and life cycle management to exchange knowledge and collaborate in a neutral setting. DIA is an essential resource that provides opportunities to extend debate and discussion to advance scientific and medical innovation. ((https://web.archive.org/web/20200930182011/https://www.diaglobal.org/en/about-us))
-==== A History of Accomplishment ====
-DIA was founded in 1964 as a neutral global membership association dedicated to improving communication and collaboration in drug development. That goal remains the same today.
-The organization was born out of a true need. DIA’s founding was closely tied to the 1962 passage of sweeping legislation passed in the United States in response to the finding that use of [[:thalidomide]] to treat morning sickness caused birth defects. Although the problem was global, there was no organization at the time that could foster cooperative efforts across the entire world. Seeing the need, a group of 30 pharmaceutical professionals, medical writers, and academics created DIA as a fully independent unbiased association.
-The neutral posture of DIA encourages active participation. Because membership spans all aspects of health care product development and life cycle management, members are free to collaborate fully as they explore fresh ideas and think outside of their traditional fields. Today, DIA is a worldwide organization in more than 80 countries with regional offices covering the Americas, Europe, Asia, the Middle East, and Africa. ((https://web.archive.org/web/20210925084443/https://www.diaglobal.org/en/about-us/leadership-governance/Council-of-Regulators?Committeeid=42268555))
-==== Organizational Structure ==== {{ ::dia_leadership.png?400|}}
-Our leadership and governance model is designed as an inter-dependent system, where specialists exchange expertise to ensure clear strategic direction, relevance, and greater impact. Our Board of Directors works collaboratively with Advisory Councils, with a director sitting on each council, bringing their unique knowledge and perspectives to DIA’s mission. The highly skilled Executive Leadership Team translates the insights and guidance from the Board and Advisory Councils into action plans that benefit our members and the communities they serve.
-==== Leadership ====
-The Council of Regulators contributes essential, nuanced, and collective insights on the common interests of regulatory bodies from around the world.
-Peter Bachmann
-Chair
-[[:Peter Bachmann]] is acting as the German NtA Member, a Member of the European Union Network Data Board and the EU IDMP/SPOR Task Force, the HMA WG ‘Better Use of Medicines’/'ePI Task Force', the [[:International Pharmaceutical Regulators Programme]] (IPRP) Management Committee, and the European Lead of the ICH IGDG (Informal Generic Discussion Group). He has studied biology and chemistry and has a PhD in Pharmaceutical Biology, University of Wuerzburg (Germany). Following a JSPS postdoctoral fellowship at Kyoto University and a DFG Fellowship at the Institute of Food Research Norwich/UK, he has worked at the [[:Institute of Pharmaceutical Biology]], TU Braunschweig/Germany, until he joined in 1999 the BfArM, Department of Drug Approval.
-Fellow of DIA
-Melanie Carr
-[[:Melanie Carr]] is Head of the [[:Stakeholders and Communication Division]] and a member of the Executive Board at the [[:European Medicines Agency]] (EMA). She joined EMA in 1996 and has held various roles in pharmacovigilance, the centralised procedure for marketing authorisation, orphan medicines, the SME office and corporate stakeholders department. In her current role she is responsible for stakeholder relations management and communication. She has a degree in Pharmacy from the University of Nottingham in the UK and worked as a regulatory professional in the pharmaceutical industry prior to joining EMA.
-=== Leadership Committee ===
-Gerald J. Dal Pan
-[[:Gerald J. Dal Pan]], MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the WHO Advisory Committee on the Safety of Medicinal Products, he served on the [[:Council of International Organization of Medical Sciences]] and the [[:International Council on Harmonisation]]. He received his MD from [[:Columbia University]] College of Physicians and Surgeons and his Master of Health Science in Clinical Epidemiology from the [[:Johns Hopkins University]] School of Hygiene and Public Health. Before joining FDA, he was a faculty member in Neurology at [[:Johns Hopkins]].
-Rogerio S. Gaspar
-Dr. [[:Rogério Gaspar]] from Portugal joined WHO January 6, 2021, as the Director of Regulation and Prequalification Department. He obtained his PhD in Pharmaceutical Sciences from the Catholic University of Louvain Belgium in 1991, after a graduation as pharmacist from the University of Coimbra Portugal. He was a Full Professor at the Faculty of Pharmacy University of Lisbon until the end 2020, where he was Head of Department and President of the School Council. He was a member of the management board of EMA and VP of the management board at Portugal’s NRA (INFARMED). He also participated in activities against medicines counterfeiting and from 2000-2002 lead the participation of Portugal within International Narcotics Control Board (INCB).
-Yee Hoo Looi
-[[:Yee Hoo Looi]], PhD, is Deputy Director of Therapeutic Products Branch of the Health Products Regulation Group, [[:Health Sciences Authority]] (HSA), which administers the regulation and pre-market evaluation for drug registration in Singapore. Dr. Looi started his HSA career as an evaluator for both clinical and toxicology review, and currently leads non-clinical evaluation and helps to oversee benefit-risk assessment for marketing approval. Prior to joining HSA, he conducted safety assessments of drug candidates as an industry pharmacologist. Dr. Looi earned his PhD in Pharmacology from the [[:University of Strathclyde]] (United Kingdom), and completed his post-doctoral training, focusing on heart failure research, at [[:King’s College London]].
-Celia Lourenco
-[[:Celia Lourenco]], PhD is the Director General of the [[:Biologic and Radiopharmaceutical Drugs Directorate]] (BRDD) of the [[:Health Products and Food Branch of Health Canada]]. She was previously the Senior Executive Director of the [[:Therapeutic Products Directorate]] (TPD) and held other management positions within TPD over a period of about 10 years. In her various management roles, Celia has been responsible for the review and authorization of a variety of new drugs for human use, either for clinical trials or for market authorization in Canada. Celia represents [[:Health Canada]] at the Assembly and Management Committee of the International Council for Harmonization and at the Management Committee of the [[:International Pharmaceutical Regulators Programme]].
-Younjoo Park
-Dr. [[:Younjoo Park]] serves as Director General of the Drug Evaluation Department at the Ministry of Food and Drug Safety, Republic of Korea since March 2021. Dr. Park is responsible for overall drug review and approval, pharmaceutical standardization, and generic drug review. For 20 years after joining MFDS, Dr. Park took charge of several divisions as Director including oncology and antimicrobial products, recombinant protein products, and cell and gene therapy products etc. Before the current position, Dr. Park served as Director General of Pharmaceutical and Medical Device Research Department in 2019-2021. Dr. Park obtained her Ph.D. in pharmcology from Seoul National University in 2001.
-Joerg Schlaepfer
-Dr. [[:Jörg Schläpfer]], PhD is the Head of Communication and Networking and Member of the Management Board of [[:Swissmedic]]. He studied Veterinary Medicine at the University of Berne, completing his studies in 1991. After obtaining the title of Doctor of Veterinary Medicine, completing his PhD and undertaking 12 years of academic research, **he was employed by a number of companies in various roles within the pharmaceutical industry from 2002 to 2015**. Since the end of 2015, Jörg Schläpfer has been Head of Division Process Development and Support in the Authorisation sector at Swissmedic as well as Deputy Head of the sector.
-Hiroshi Suzuki
-Dr. [[:Hiroshi Suzuki]] is the Director of [[:Center for Regulatory Science]], PMDA, since April 2020. He is also serving as the Professor & Chair and Director of Department of Pharmacy, The [[:University of Tokyo Hospital]], Faculty of Medicine, The University of Tokyo, since June 2004, and is responsible for the management of the activities of approximately 90 hospital pharmacists, research and education. His major field is the molecular pharmacology (analysis of metabolic and locomotive syndromes) and clinical pharmacology (PK/PD, pharmacometrics, and systems-biology) which are closely related to the regulatory sciences. ((https://web.archive.org/web/20210925084443/https://www.diaglobal.org/en/about-us/leadership-governance/Council-of-Regulators?Committeeid=42268555))
-==== Student Chapters ====
-ABOUT DIA AND OUR STUDENT CHAPTERS
-DIA is a global, member-driven organization that mobilizes life sciences and healthcare professionals from all areas of expertise in a neutral environment to discuss global and local challenges facing the life sciences field in an increasingly more complex and interconnected world. DIA’s goal, and our members’ hope, is for this collaboration to result in better policies, regulations, science, research and development, and ultimately
-better patient outcomes worldwide. Founded in 1964 in the wake of the Thalidomide crisis, DIA’s efforts emphasize the drug development and utilization life cycle.
-Student Chapters are self-enabling organizations that operate under a charter and guidelines delineated by DIA to ensure growth and sustainability. A Student Chapter is comprised of a group of at least five (5) DIA student members, a Student Chapter Advisor (faculty member), and a Hosting Institution whose purpose is to promote an affiliation with DIA and serve the needs of students for multidisciplinary networking and information exchange. If your school doesn’t have a student chapter you can start your own. ((https://web.archive.org/web/20220830185807/https://www.diahome.org/en/-/media/diaglobal/files/get-involved/students/student-chapters.pdf))
-STUDENT-LED EVENTS
-Student Chapters host events online and on campus to provide students opportunities to meet and learn from industry professionals and to engage with other students while building their professional network.
-STUDENT CHAPTER NEWSLETTER
-The Annual Newsletter highlights each Chapter and its president and shares information about their progress and most impactful events through the year.
-DIA NOW
-Keeping up-to-date with insights on challenges facing the life sciences field is vital to professionals involved in the development of drugs, biologics, and medical devices across the product life-cycle. DIA NOW is the only source of industry-driven original, actionable content delivered by experts in the field, and with access to recorded sessions from more than 60 meetings annually, along with breaking news and analysis, DIA NOW provides a robust, constantly-refreshed source of global trends and information. DIA NOW is available to Student Chapter Members, click below for more information.
-==== DIA 2021 Global Annual Meeting ====
-Opening Plenary Panel: Combating [[:Misinformation]] in Health and Health Care
-Jun 27, 2021 10:00 AM – Jul 01, 2021 4:30 PM  Virtual Event   No charge
-DIA Global Annual Meeting - Opening DIAmond and Plenary Session
-Jun 28, 2021 10:00 AM – Jun 28, 2021 11:45 AM
-[[:Barbara Lopez Kunz]], MBA, MS, MSc
-Global Chief Executive - DIA, United States
-We are excited to welcome you to the DIA 2021 Virtual Global Annual Meeting
-Join us for the Global Annual Meeting Welcome Remarks, Keynote Address, and Opening DIAmond Session!
-Keynote Address: [[:Kenneth Frazier]], JD, Chairman of the Board and Chief Executive Officer, [[:Merck]] & Co.
-For most of us, the novel coronavirus represents an unprecedented time in our lives. However, history is full of accounts of humans grappling with viral invaders, and the positive innovations and learnings that we derive from these circumstances. Ken Frazier, Chairman and CEO of Merck, reflects on the discoveries that were made during pandemics of the past and their durable effects on science and society.
-Mr. Frazier also discusses the adaptations and accelerations required to develop vaccines and therapeutics to address the current pandemic, and their implications for the future of drug development. The lasting transformations of the COVID-19 pandemic may yet to be fully characterized, but we know they will be documented in the history books.
-Opening Plenary Panel: Combating Misinformation in Health and Health Care
-The COVID-19 era has been characterized by a strong [[:anti-science]] bias among large swaths of the public in many countries. This includes those who deny the existence of COVID; those who oppose vaccines based on spurious science, correlation that does not reflect causality, or an unsupported belief that vaccines are untrustworthy or harmful; those who believe that science comes from an elite that may not have the best interests of the general public at heart; and many others.
-**All of these beliefs pose significant challenges to public health efforts to contain the spread of COVID and encourage widespread vaccination.** The problem is compounded by the tremendous amounts of misinformation that have been circulating since the beginning of the pandemic. This [[:misinformation]] has been promulgated through many channels, particularly on social media. While reputable sources have made many attempts to remove or discredit such information, these efforts have been far from successful. People also continue to receive misinformation from family, friends, and public figures.
-The panel will address the following high-level topics:
-      * How does misinformation about health and health care spread? Why do people believe it?
-  *     What do we know about how to successfully help people identify and question misinformation?
-  *     Who is best positioned to counter misinformation about COVID, and what do we know about how to do so effectively?
-  *     Are there specific approaches to combating misinformation that can help address known disparities in health and health care, particularly those that are COVID-related?
-Learning Objective : Identify two ways in which misinformation about health and health care spread; Identify one way in which to counter misinformation about COVID-19 effectively; Describe how known disparities in health and health care relate to the spread of misinformation about COVID-19.
-Speaker(s)
-  *
-  * Opening Remarks
-  * Judith Ng-Cashin, MD
-  *
-  *     Chief Medical Officer
-  *     [[:Eagle Pharmaceuticals]], United States
-  *
-  *
-  * Honorary Co-Chair
-  * [[:Emer Cooke]], MBA, MSc
-  *
-  *     Chair, ICMRA; Executive Director
-  *     [[:European Medicines Agency]], Netherlands
-  *
-  *
-  * Honorary Co-Chair
-  * [[:Janet Woodcock]], MD
-  *
-  *     Acting Commissioner
-  *     [[:Food and Drug Administration]], United States
-  *
-  *
-  * Honorary Co-Chair
-  * Yasuhiro Fujiwara, MD, PhD
-  *
-  *     Chief Executive
-  *     [[:Pharmaceuticals and Medical Devices Agency]] (PMDA), Japan
-  *
-  *
-  *
-  * Introduction of Keynote Speaker
-  * [[:Michael Rosenblatt]], MD
-  *
-  *     Chief Medical Officer
-  *     [[:Flagship Pioneering]], United States
-  *
-  *
-  *
-  * Keynote Speaker
-  * Kenneth Frazier, JD
-  *
-  *     [[:Chairman of the Board]] and [[:Chief Executive Officer]]
-  *     [[:Merck]] & Co., Inc., United States
-  *
-  * Susan C. Winckler, JD, RPh
-  * Moderator: Combating Misinformation in Health and Health Care
-  * Susan C. Winckler, JD, RPh
-  *
-  *     Chief Executive Officer
-  *     [[:Reagan-Udall Foundation]], United States
-  *
-  *
-  * Panelist
-  * [[:Briony Swire-Thompson]]
-  *
-  *     Senior Research Scientist, Lazer Lab
-  *     [[:Northeastern University Network Science Institute]], United States
-  *
-  *
-  * Panelist
-  * [[:Brian Southwell]], PhD
-  *
-  *     Senior Director, Science in the Public Sphere, [[:Center for Communication Science
-  *     RTI International]], United States
-  *
-  *
-  * Panelist
-  * [[:Melanie Carr]]
-  *
-  *     Head of Stakeholders and Communication Division
-  *     [[:European Medicines Agency]], Netherlands
-  *
-  * Panelist
-  * [[:Richardae Araojo]], PharmD, MS
-  *
-  *     Associate Commissioner for Minority Health, Director, Office of Minority Health
-  *     (FDA) [[:Food and Drug Administration]], United States ((https://web.archive.org/web/20211027074601/https://www.diaglobal.org/en/conference-listing/meetings/2021/06/dia-2021-global-annual-meeting/agenda/28/dia-global-annual-meeting-opening-diamond-and-plenary-session?ref=DIAGlobalAnnualMeetingOpeningDIAmondandPlenarySession))