DIA 2018 Call for Topics

DIA and the Annual Meeting Program Committee (AMPC) want to hear from you! Submit a topic during our DIA 2018 Call for Topics. This is your opportunity to share your suggestions on thought provoking, trending, and timely topics that are important to you, your colleagues, and the DIA community.

Topic submissions will be reviewed by the AMPC to assist with the content development and strategy for DIA 2018. Submission of a topic is not in any way related to a speaking role at DIA 2018. An open Call for Abstracts will be available in the fall of 2017 to solicit sessions and presentations for DIA 2018.

Below are four different examples of a suggested topic:

• Considerations for pre-launch health care communication with payers
• Best Practices for implementing the ISO IDMP standards
• Recent regulatory pathways and policies related to personalized medicine in the US
• Effective strategies for collaborations among industry, academia, and health authorities

Submit a topic to DIA 2018

View tracks and included topics areas

• Regulatory

  Global and US Advertising and Promotional regulations and laws; Regulatory Operation best practices; Regulatory Intelligence; Developments in regulatory science; eSubmissions; regulatory document management, biosimilars, combination products, companion diagnostics; compliance

• Safety and Pharmacovigilance

  Safety/Pharmacovigilance best practices; guideline updates; Benefit-Risk Assessment; Risk-based monitoring; document management, biosimilars; post-market safety considerations; combination products; companion diagnostics; compliance; ICH(E); audit/inspection

• Clinical Trials and Clinical Operations

  Personalized medicine, gene editing, clinical trial recruitment and retention; patient engagement, site management; Specific Therapeutic Areas; endpoints/COA’s (Patient-reported outcome (PRO) measures, clinician-reported outcome (ClinRO) measures, observer-reported outcome (ObsRO) measures, and performance outcome (PerfO) measures; COA Compendium); Specific Therapeutic Areas; telemedicine, eHealth, mobile health, wearables, eHR, clinical trial diversity, collaborations; stem cells, regenerative therapies, gene therapies, etc., ICH(E); GCP, audit/inspection

• Data/ Data Standards

  Informatics, Data Standards and Standardization, Data Management, Data Quality, Data Systems; Data Integration, compliance, bioethics, security, data privacy, transparency, Big Data, data sources (eHR)

• Medical Affairs and Scientific Communication

  Medical Info; Medical Science Liaison; Medical Writing; Medical Affairs Roles throughout Product Lifecycle, Stakeholder Management, Advisory Boards, compliance

• Quality

  ICH Q, CMC, GMP, audit/inspection, compliance

• Statistics

  Adaptive Design; Bayesian Statistics; Informatics; bioinformatics; analytic standards, data visualization

• Project Management and Strategic Planning

  Portfolio management, Project management, Transformative partnerships, Funding; Global compliance, product life cycle planning, global commercialization considerations

• Preclinical Development & Early Phase Clinical Development

  Personalized Medicine; Gene Editing; Clinical trial data disclosure, Clinical trial data disclosure; Collaborations; bioethics; compliance; stem cells, regenerative therapies, gene therapies, etc.; ICH (S), study endpoints

• Value and Access

  Comparative Effectiveness Research, Health Technology Assessment, Real World Outcomes, Value Based Healthcare; Drug Pricing, Reimbursement and Access, Commercialization, Drug Product Lifecycle Considerations