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Health Care News

Best Practices and Industry News

October 2014

Changing Regulatory and Commercial Climate Puts Affiliate Model Under Spotlight

Ensuring Operational Excellence in Drug Safety: Quality Management Systems

IDMP Creates Both Opportunities and Challenges in Managing Company-Wide Data

Model for Transforming a Pharmaceutical Medical Information Organization to Meet the Needs of the Emerging Healthcare Landscape

Preparing to Submit FDA2253 through the ESG: What can we expect and what will the process look like?

Tomorrow's Trials: Perceived Barriers to Going Paperless Crumble in the Cloud

Transforming Recruitment for Clinical Trials via Patient Social Networks

DIA 2014 50th Annual Meeting Student Session Reports

Monday, June 16

View Session 107. Pioneering Regenerative Medicine: Trends in Regulations for New Therapy

View Session 129. Regulatory Submissions: Better, Faster, and Cheaper

Tuesday, June 17

View Session 211. Clinical Outcomes Assessment & Patient Engagement Symposium

View Session 215. The Regulatory Intelligence Function: Evolution over the Past Decade in an Expanded Global Marketplace

View Session 221. Benefit-Risk Throughout the Life Cycle: How Should Benefit-Risk Be Evaluated and Communicated from Development through Marketing as New Information Emerges?

View Session 246. EMA-FDA Collaboration in Pharmacovigilance: Common Objectives & Common Challenges

View Session 262. First-in-Human Studies: How Much Complexity Is Too Much?

Wednesday, June 18

View Session 319. Signal Detection: Challenges & Strategic Aspects

Best Practices and Industry News

April 2014

Document Management for Labeling

Good Data Discipline: Responding to New XEVMPD Maintenance Guidelines

Getting Ready for the PSMF (Pharmacovigilance System Master File)

DIA 2013 49th Annual Meeting Student Session Reports

Monday, June 24

View Session 119. Hot Topics in Statistics: Working Together Effectively to Transform Our Science

View Session 123. How Can Translational Medicine Fill The Gaps in Life Sciences Industries?

View Session 130. Translational Aspects from Preclinical Animal Toxicology Studies to Early Human Health Risk Assessment: Needs and Limitations

View Session 143. Key Multiplicity Issues in Clinical Trial

View Session 144. The Secret of Stellar Careers: Serendipity + Planning = Success

Tuesday, June 25

View Session 220. Biomarkers for Drug Development: How are we dealing with the challenges?

View Session 234. Strategies for the Development and Registration of Antibody Drug Conjugates

View Session 239. Student Forum: Getting a Job & Developing a Career 

View Session 262. First-in-Human Studies: How Much Complexity Is Too Much?

View Session 277. Breakthrough Therapy: One Candle on the Birthday Cake – Are Innovators Enjoying Sweet success or Is the Pathway Not Baked Yet?

Wednesday, June 26

View Session 318. Molecular Predictors of Drug Induced Harm: From Clinical Development to Postmarketing Surveillance

View Session 332. Pharmacometrics: Implications and Impact in Preclinical to Early Phase Development

View Session 339. Drug Shortages: Causes, Current State & Path Forward

View Session 343. Challenges and Strategic Approaches to Biosimilar Development

View Session 360. Rising to the Challenge of Developing Novel Orphan Medicines for the Global Market

View Annual Meeting Student Reflections

EMA Press Release: Pharmacovigilance Risk Assessment Committee: One year of Public Health Promotion and Protection