With a wealth of sessions stretched out over the course of five days, attendees trying to plan their agenda for this year’s DIA Global Annual Meeting (taking place in Chicago June 19-23) might have a tough time making the most of their limited hours. However, the organizers have funneled the programming into 13 focused professional tracks in a way that may prove helpful in assisting the process, enabling attendees to hone on sessions that are of most interest and value to their interests.
Clinical Safety and Pharmacovigilance
These sessions offer an overview of the regulatory environment regarding clinical safety and pharmacovigilance for pharmaceutical products, advanced therapies, and medical devices. The content centers on pragmatic approaches to safeguarding patients, as well as incorporating patient voice into the process.
Clinical Trials and Clinical Operations
The programming in this track touches upon recent advances in clinical research and operations. Sessions in the funnel include discussions on design strategies, increasing efficiencies in operations, integrating patient outcomes, and more.
Data and Technology in Clinical Trials
Innovations in technology are leading to a range of benefits in study data collection in studies. This track focuses on recent advancements in clinical data curation, including data quality and standards, real-world data and evidence, wearables, machine learning, and more.
Medical Affairs and Scientific Communication
The content in this track will feature insights from medical affairs professionals and experts. The sessions will cover the skills and best practices needed for compliance in an increasingly cross-functional work environment.
These sessions are geared toward increasing the quality of patient engagement in product development, from early development and approval, going through maintenance phases. Issues addressed in the programming include patient-centric approaches, incorporating patient voice, and collaboration among stakeholders.
Preclinical Development and Early-Phase Clinical Research
Preclinical and early-phase clinical research enables pharma companies and research partners to determine initial dosing and safety data for new drugs. Sessions in this track center on strategies used in early-stage compound selection, updates on safety considerations for both drugs and biologics, how PK/PD affects dosing strategies, and methods to improve data quality and integrity for proper downstream decision-making.
Project Management and Strategic Planning
The content in his track is geared toward best practices to enhance project and program execution, strategic planning, and portfolio management. Sessions will touch upon collaborating effectively with stakeholders (internal and external) to achieve optimal efficiencies in project and program development.
R&D Quality and Compliance
Attendees following this track will gain perspective on the quality landscape across the pharmaceutical industry. Topics include GLP, GCP, and PV quality, providing knowledge and resources needed to implement pragmatic, proactive, and effective quality management.
Sessions in this group will cover global laws, regulations, guidelines, and guidances that impact prescription pharmaceutical and device development, approval, and maintenance. Organizations represented include FDA, Health Canada. NMPA, PMDA, EMA, MHRA, European Health Authorities, and ICMRA authorities.
Regulatory CMC and Product Quality
This track is intended to provide a view of risk-based approaches across the product lifecycle. Topics discussed in the sessions include increasing regulatory complexity of development and manufacturing, accelerated development timelines, new technologies, and emerging regulations.
These sessions will cover topics of statistical interest for professionals who work with pharmaceuticals, biologics and biosimilars, combination products and devices, and more. Presenters will explore current statistical thinking that informs policy, regulation, development, review, and lifecycle management of medical products.
Value and Access
Discussions in this track will touch upon how all stakeholders are impacted by the evolution of the healthcare landscape into one assessed on value. This track will bring together global regulators, industry leaders, academics, patients, and payers, discussing important issues and questions that have far-reaching impact in the area.
Attendees participating in this track will hear ways to improve growth for career and team success. Sessions include interpersonal skills, soft skills, leadership, goal setting, life-long learning, career transitions, use of social media/new media, and ways to identify strengths and room for improvement.
The DIA Global Annual Meeting is scheduled June 19-23 in Chicago. Read here for more information or to register for the event.