HORSHAM, PA.— DIA has partnered with the Food and Drug Administration to hold FDA Information Day: Individual Case Safety Reports (ICSR), November 29-30, at Silver Spring Civic Building, One Veterans Place, in Silver Spring, MD. Participants will discuss at length the latest information about the new ICSR and Identification of Medicinal Products (IDMP) standards and how they interlink, as well as the implementation planning from a national and European perspective.
These new standards reflect the changing horizon of pharmacovigilance data management, according to the DIA program planning committee. Attendees need to know the latest on the ICSR standard and how it will impact the industry. They’ll gain the right tools to navigate this new reporting model.
The sessions will begin with Lonnie Smith Policy Analyst Data Standards Council and Office of Critical Paths OC, FDA speaking about the role of the ICSR and IDMP standards in the pharmaceutical and healthcare domains. The first day will provide guidance on the new ICSR standard, and the second day will focus on best practices for implementing the standards. Overall sessions will include:
• Use of MedDRA: Focus on the New Scope of Adverse Event Reporting, presented by Patrick Revelle, Director, Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization (MedDRA MSSO), and Sonja Brajovic, Medical Officer, Center for Drug Evaluation and Research, Food and Drug Administration
• Vaccine Reporting Requirements, presented Lisa R. Stevens, Project Manager, Center for Biologics Evaluation and Research, Food and Drug Administration
• ISO IDMP: Medicinal and Pharmaceutical Product Identification and How It’s Applied in Practice, presented by Sabine Brosch, PharmD, PhD, Business Lead, EudraVigilance and International Standardisation in Pharmacovigilance, European Medicines Agency, and Vada A. Perkins, MSc, BSN, RN Regulatory Program Management Officer, Center for Biologics Evaluation and Research, Food and Drug Administration
Register for FDA Information Day: Individual Case Safety Reports (ICSR).
ABOUT DIA: DIA is a neutral, global, professional and member-driven association of nearly 18,000 professionals involved in the discovery, development and lifecycle management of pharmaceuticals, biotechnology, medical devices and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well-being worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; Beijing, China; Washington, D.C.; and Latin America. Visit our website at www.diahome.org; follow DIA on Facebook, Twitter (#druginfoassn), LinkedIn, Flickr and YouTube.