1964
The Drug Information Association (DIA) was founded in 1964 and incorporated in the state of Maryland, USA. A nonprofit, scientific, member-driven association, DIA evolved from a founding group of 30 professionals employed in academia and the pharmaceutical industry, into a multidisciplinary organization with over 23,000 members in 80+ countries in 2005.
1964-1979
Initially, the DIA President managed the records, meetings and financial matters. Meetings consisted of an Annual Meeting and an occasional additional meeting on a specific topic. During the latter part of the early period, 1964-1979, Ms. Claire R. McDonnell managed the association.
1979-1992
In 1979, Mr. Thomas W. Teal, (Cdr., USN Ret.) was employed as the Executive Director of DIA and as Editor-in-Chief of the Drug Information Journal. During this period, DIA membership and activities increased substantially. The number of meetings, training courses, and symposia grew to over 30 per year, including meetings in Canada, Europe, and Japan.
In 1989, the North American Steering Committee (now known as the Advisory Council of North America) was established, followed by a Steering Committee for Europe (now known as the Advisory Council of Europe) and Southwest Asian Pacific. DIA established a European office in Basel, Switzerland, in 1991. A DIA office in Sydney, Australia soon followed the European office. (This office has since closed.) In January 1999, the DIA office in Tokyo, Japan opened.
1992-2004
In 1992, Mr. Teal retired from the position of Executive Director but continued his position as Editor-in-Chief of the Drug Information Journal.
Mr. Erich F. Lukas Jr., was employed as Executive Director. Mr. Lukas’s tenure continued through 1995. During that time, the concept of committees organized to address particular topics through meetings and workshops on a recurring basis was expanded. The DIA website http://www.diahome.org became operational in April 1996.
In July 1996, Joseph R. Assenzo, PhD, was employed as Executive Director. He continued to serve in this position until 2004.
2005
The Board of Directors approved a new Volunteer Awards program that advanced two of the association's major strategic initiatives: continued efforts to make the DIA volunteer experience as rewarding as possible, and improved transparency in communications among all DIA constituents.
DIA responded to membership needs in Japan with a new paradigm for delivering educational content that more accurately reflected the modern, global and multidisciplinary pharmaceutical industry environment with the 1st Multitrack Workshop in Japan: DIA Congress on the Development & Utilization of Pharmaceuticals in September. This first multitrack offering in Japan was also the first DIA workshop in Japan to be officially and simultaneously endorsed by the Ministry of Health, Labor & Welfare; the Pharmaceuticals and Medical Devices Agency; and the Japan Pharmaceutical Manufacturers Association.
At its December meeting, the Board of Directors changed the status of the Advisory Council of Japan from provisional to full.
2006
In March, members from all three Regional Advisory Councils convened for the first time, prior to the Paris EuroMeeting. In November, DIA held the first SIAC Leadership Summit in Dublin, bringing together SIAC chairpersons from Europe and North America.
The Annual Meeting in Philadelphia featured several "firsts," including the first DIA appearance by the Drugs Controller General of India and the FDA's first public update on the FDA's Human Subject Protection / Bioresearch Monitoring Initiative. In addition, representatives of the EMEA and FDA jointly announced that the EU / FDA Confidentiality Agreement, originally created in 2003 as a two-year arrangement, had been extended to September 2010. This Annual Meeting also featured a special reception honoring the one hundredth anniversary celebration of the FDA.
In response to requests from the Middle East's drug regulatory authorities, DIA conducted a workshop in Dubai in partnership with the Middle East Regulatory Network. Themes discussed during this May workshop were advanced to the 7th Middle East Regulatory Conference: MERC 2006 conducted in November in Dubai, attended by representatives from eleven Middle East regulatory authorities.
Jointly organized with the Institute of Clinical Research (India) and with collaborative sponsorship from Biomedical Consulting International, Inc., DIA presented Drug Discovery & Clinical Development in India: Opportunities & Challenges in Mumbai in October. Two pre-conference tutorials were specially targeted at graduate post-medical students in clinical research and pharmacy, and were rewarded by sizable percentages of attendees who were students from Delhi, Bangalore and Mumbai.
By the end of 2006, the EMEA EudraVigilance training program, with DIA serving as conference organizer, had trained more than 1,000 users with skills required to efficiently manage the new concepts of electronic reporting that became mandatory in the EEA in November 2005.
2007
The Board launched the Strategic Plan Update Project to assess emerging issues and created Task Forces to target specific content area goals: Communities, for enhancing DIA’s communities structure, including expanding/establishing communities in China and India; Technology, to evaluate tools that leverage content for delivery to DIA’s global stakeholders; Scientific/Regulatory, to refine existing and develop new DIA educational offerings; and Geographic, to develop and implement DIA’s strategic expansion into China and India. The Board also approved the formation of the provisional Advisory Council of India to support DIA initiatives in the region.
The 19th Annual EuroMeeting in Vienna, Austria, demonstrated DIA’s unique capability for bringing regulators and their constituencies together for meaningful discussion of common goals and interests. EuroMeeting featured speakers included the Director of the Directorate for Consumer Goods, European Commission, DG Enterprise & Industry, EU; the Director General, EFPIA; and the Executive Director, EMEA, EU. DIA also developed and delivered a new educational paradigm in Europe with the cross-functional 1st DIA Clinical Forum in Europe.
In addition to the traditional tracks that make it the pharmaceutical industry’s event of the year, the 43rd Annual Meeting in Atlanta featured four “hot topic” tracks dedicated to adaptive trials, the FDA Critical Path Initiative, global clinical trials, and personalized medicine. Keynote speakers included the Chief Strategy & Innovation Officer for the US Centers for Disease Control & Prevention.
In Japan, DIA presented the 1st Conference in Japan for Asian New Drug Development, focused on global clinical trials in China, Hong Kong, India, Korea, Singapore, and Taiwan. Elsewhere, DIA collaborated with IFAPP, SAMEFA, and SBMF to present the 4th Latin American Congress of Clinical Research in Sao Paolo, Brazil; and the DIA, ICRI & BCI 2nd Annual Conference on Drug Discovery & Clinical Development in India.
2008
DIA established the Advisory Council of China and our office in Beijing, and signed a memorandum of understanding with the China Center for Pharmaceutical Industry Exchange “to advance China’s participation in global drug development through information sharing and training.” In India, DIA established our office in Mumbai and presented our 1st Annual Regulatory Conference in India.
2008 celebrated our anniversary 20th Annual EuroMeeting in Barcelona, Spain, which introduced the innovation of arranging certain multidisciplinary sessions into broad themes, so that attendees could still follow sessions tracked to their specific professional discipline, yet move between themes to share viewpoints with experts from other disciplines. The expanded Patient Fellowship program at this EuroMeeting featured the first Patient Fellowship booth on the exhibit floor.
In North America, DIA collaborated with FDA to present two “by invitation only” Critical Path Initiative workshops. The 44th DIA Annual Meeting, in Boston, was the largest, most well-attended event in DIA history, and introduced the new concept of Mega Tracks for Clinical Research and Information Technology to promote broader discussion and understanding of these essential industry concepts. DIA also celebrated the 20th anniversary of our annual Workshop on Marketing of Pharmaceuticals.
The DIA Philanthropy Program offered training in Uganda that overviewed the US regulatory drug approval process, sponsored by the Makarere University Walter Reed Project, a collaborative not-for-profit research effort that combats the region’s endemic diseases. DIA also co-sponsored our African Regulatory Conference in Fourways, Johannesburg, with the Southern African Development Community, in partnership with the African Regulatory Network; and presented our first Safety is Global: Contemporary Pharmacovigilance & Medical Product Risk Management Strategies conference in Singapore. Our 1st DIA Regulatory Affairs Training Course in Japan premiered in Tokyo.
2009
DIA launched a new publication in 2009, the Global Forum, which provides members globally-focused information from China, Europe, India, Japan, Latin America, and North America, plus a special Patient Perspective feature. The Global Forum editorial board includes a student member, the first for a DIA publication.
DIA presented our 1st Training Workshop in China: Understanding Statistical Thinking in Clinical Research, and hosted our 1st DIA China Annual Meeting in collaboration with the China Center for Pharmaceutical International Exchange of the State Food & Drug Administration.
DIA presented our debut conference on the emerging field of Personalized Medicine, advanced new content areas in Europe through our debut DIA Biosimilars Workshop 2009, and hosted the first joint 3rd Paediatric Forum & EFGCP Children’s Medicines Working Party 5th Annual Conference. The Advisory Council of Europe also presented a special free workshop – Medicinal Products: Latest News from the European Regulation – convened in Budapest among expert representatives from France, Germany, Hungary, the Netherlands, Slovakia, and the European Medicines Agency.
Leadership from the FDA, WHO, Bill & Melinda Gates Foundation, International Vaccine Initiative, Developing Countries Regulatory Network, and BIO Ventures for Global Health, convened at DIA’s first Global Vaccine Development for World Health Symposium. DIA expanded into another new content area with our debut workshop on Dried Blood Spot (DBS) Sampling in the Pharmaceutical Industry, co-sponsored with PhRMA.
In India, DIA presented consecutive offerings of our 1st Workshop on Pre-market Evaluation of Quality & Bioavailability in Mumbai and Hyderabad, and our first meeting in India on Industry & Regulatory Perspectives on CMC Compliance. In Japan, DIA presented our 1st DIA Regulatory Communications Workshop in Japan and concluded two offerings of our 1st Regulatory Affairs Training Course in Japan. Online, our first-ever Annual Meeting Online, a selection of webinars across a range of sessions and topics, delivered live Annual Meeting presentations to participants who could not attend our 45th Annual Meeting in San Diego.
In the context of a rapidly changing global health care landscape, DIA continued to present an international array of Annual Meetings; in addition to China and the US, these included Annual Meetings in Canada, Europe, and Japan. DIA also announced new Vision and Mission statements in 2009 that raised our association’s role from a neutral venue for sharing information to one that facilitates knowledge required to elevate the level of health and well-being worldwide.
2010
In February, DIA and the Chinese Pharmaceutical Association (CPA) signed a memorandum of understanding for collaborating on a quarterly Chinese language DIA/CPA newsletter and on global and regional professional education opportunities. We presented our first DIA-ACT-CST Study Director Workshop in Beijing, in collaboration with the American College of Toxicology and the Chinese Society of Toxicology, in October. The first DIA/CPA Global Pharmaceutical Forum was published in November.
Working in collaboration with the World Health Organization and the European Directorate for the Quality of Medicines and HealthCare, DIA presented our Quality of Active Pharmaceutical Ingredients Workshop in Mumbai, India. We presented our 1st Cardiac Safety Workshop in Japan to support implementation of the ICH E14 cardiac safety guideline, and, with the South African Development Community as co-sponsors, presented our 2nd DIA African Regulatory Conference in Johannesburg, a program developed by the Africa Regulatory Network of the European Federation of Pharmaceutical Industries and Associations and other advisors.
In Ottawa, Ontario, DIA presented our first Annual Canadian Meeting (our eighth in total) in collaboration with the Clinical Research Association of Canada; this was also the first Annual Canadian Meeting to simultaneously webcast a tutorial for those unable to attend in person. Other North American conferences on multiregional clinical trials, global risk management, clinical development of stem cell therapies, evidence-based medicine, adaptive design, and other topics, served to illustrate and advance DIA’s expanding strategic vision.
FDA Commissioner Dr. Margaret Hamburg served as Keynote Speaker at our 46th Annual Meeting, which featured interactive regulatory sessions with senior regulatory leadership from Japan, Europe, and CDER, plus, for the first time at our Annual Meeting, representatives of CBER and CDRH. This meeting also featured our first Annual Meeting Executive Policy Forum.
DIA’s twenty year history of statistical workshops in Europe culminated in our 1st Joint DIA/EMA Workshop on Statistical Methodology in Clinical Research & Development, presented in September. DIA and the European Forum for Good Clinical Practice collaboratively presented our first DIA/EFGCP Workshop on Pharmacovigilance Audits & Inspections in October. In 2010, DIA also presented our debut conferences on orphan drugs and combination products in Europe.
In November, DIA’s global and multidisciplinary network came together to present the DIA 2010 Korea Meeting, which was endorsed by DIA in partnership with the Korean Society of Pharmaceutical Medicine and the Korea National Enterprise for Clinical Trials, who served as hosts.
The ability of DIA members and volunteers to collaborate in our global, multidisciplinary professional network entered a new era with the December 2010 launch of DIA ConneX, a members-only social networking platform, securely hosted on our website, that allows DIA SIAC members to network and collaborate online with professional colleagues all around the world.
The Board of Directors officially established our first Steering Committee of Latin America, comprised of representatives from Argentina, Brazil, and Mexico, to be supplemented by additional members from Chile and Central America to provide regional insight and representation. The Board also approved strategic initiatives that construct three distinct building blocks from our DIA vision – digital strategy, market development, and quality improvement – to provide the foundation for the future of DIA.