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-===== DIA Global =====
-Expert PR Crisis Management Communications
-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.
-==== 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))
-==== 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
-Fellow of DIA
-[[: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.
-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.
-Gerald J. Dal Pan
-Leadership Committee
-[[: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))