cross corporate, regulatory, and international boundaries, DIA’s Communities and Working Groups serve as easily accessible hubs for stimulating, peer-to-peer discussions, professional networking opportunities, lively idea exchanges, and high-quality content created by our members.

• In 2017, we added seven new working groups across the currently more than 20 DIA Communities.
• On July 4, 2017, DIA Japan held its 1st DIA Japan Community Day, subtitled “I have learned everything necessary for life in the DIA Community.”
• Re-energized in 2017, the Devices and Diagnostics Community put forward an outstanding activity schedule for 2018 that includes webinars, presentations, and thought-provoking discussions on cutting-edge topics affecting the field.
• The recently launched DIA Grand Challenges Program allows DIA Community members to identify the most pressing problems in their respective fields and work together to find solutions that move both the field and the global healthcare industry forward. Results will be announced mid-2018.
• The Leader of Tomorrow Program and its accompanying App were piloted in Europe in 2017 to engage students and emerging professionals in networking and career development. The program will expand globally in 2018.

Members participate in DIA Community Roundtable Discussions, DIA 2017 Global Annual Meeting

Why this matters: DIA Communities offer our members exclusive access to global conversations around healthcare. DIA members work together to speed innovation in healthcare product development, producing resources such as tools, case studies, and best practices that benefit the entire healthcare ecosystem.

As we expand the global reach of our mission, we strive to engage our members in insightful dialog and knowledge exchange. Particularly active communities include our Clinical Safety and Pharmacovigilance, Clinical Trial Disclosure, Good Clinical Practices and Quality Assurance, Patient Engagement, Regulatory Affairs, Statistics, and Study Endpoints Communities. These communities added a total of seven new working groups:

• The DIA Clinical Trial Disclosure (CTD) Community added four new working groups (WGs) to specifically address the implementation of recent CTD guidelines and other issues related to the evolving global CTD landscape – the CTD EMA Policy 0070 WG, CTD Final Rule WG, CTD Plain Language Summary WG, and the CTD Global Registry WG. Following intense discussions on the final rule and its implications, the CTD Final Rule WG published an article in Global Forum clarifying the purpose and requirements of the Rule.
• The DIA Interdisciplinary Disclosure WG was formed as a collaborative cross-community working group to foster dialogue among members affected by various international clinical trial disclosure requirements and interested in developing a global resource to help implement the different disclosure initiatives in the biopharma industry. The resource will be presented at the 2018 Global Annual Meeting and submitted for publication.
• The DIA Study Endpoint Community responded to the rapid spread of wearable technology into the healthcare sector and the absence of regulatory guidelines by founding a Wearables Working Group where members debate and work to advance the clinical validity of wearable-derived data to support study endpoints. The group plans to publish an “Evidence Dossier” – a proposed template for the evidence needed to support the use of wearables in clinical trials.
• The DIA-ASA Drug Safety Management Working Group, a new cross-community collaborative working group that formed as an off-shoot of the DIA Statistics and DIA Clinical Safety and Pharmacovigilance Communities, addresses the growing need for a systematic approach to safety evaluation of pharmaceutical products and develops quantitative solutions for safety monitoring during clinical development.

The Young Professionals and Students and PETD Community hosted a series of monthly Career Development webinars with professors, regulatory professionals, and executives from pharmaceutical industries and government regulatory agencies, who would share career advice for moving forward in the field. With its 2018 activity schedule, the Devices and Diagnostics Community seeks to increase awareness of the intersections among medical devices, in vitro diagnostics, and chemical and biological drugs.

Community Days gather DIA members to vitalize global Community activities and provide networking opportunities for our members. At the 1st DIA Japan Community Day, Lightning Talks, World Café dialogues, and other interactive sessions enabled the 50 attendees to share ideas and best practices across Communities and build strong networking relationships in a lively, yet relaxed setting. Participants included leaders of the various Japan Communities and representatives of PMDA and academia.