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Nov 29 2012 8:45AM - Nov 30 2012 12:00PM | Silver Spring Civic Building
One Veterans Place
Silver Spring, MD 20910
The new Individual Case Safety Reports (ICSR) standard and the International Conference on Harmonisation (ICH) E2B(R3) Implementation Guide are the next major changes on the horizon. Pharmacovigilance data management will never be the same.
ICSR is a Health Level Seven (HL7) standard for the capture of the information needed to support the reporting of adverse events, product problems or consumer complaints associated with the use of FDA regulated products. HL7 ICSR will be used as the FDA baseline data exchange standard, and is currently being pilot tested to support FDA’s transition to a unified electronic environment for managing all FDA-regulated product information for adverse event reports, product and consumer complaints, and product problem reports. HL7 ICSR Release 1 was approved as an American National Standards Institute (ANSI) Standard in 2005, and has been piloted to support electronic medical device reporting (eMDR) for CDRH. The new ICSR Release 3 which has been elaborated as an SDO Joint Initiative between three standards development organizations CEN, HL7, and ISO provides support for adverse event reporting for all FDA regulated products.
Both FDA and EMA, which have been closely collaborating on the standards development, are in the process of preparing new guidance concerning the use of the ICSR for regulatory reporting purposes. The use of MedDRA in the context of the ICSR reporting and FDA’s new MedDRA coding policy at LLT level will be also presented.
FDA is organizing this “Information Day” with input from the EMA to provide the latest information about these standards, the pilot testing and the implementation planning. The achievement of an ICH step four ICSR Implementation Guide will be also presented in the context of the overall planning including key comments received as part of the step three public consultation and the way they have been resolved. Included in the ICSR implementation strategy is the future ISO Identification of Medicinal Products (IDMP) standard. The IDMP standards support the regulation of medicines and pharmacovigilance activities including ICSR reporting. The important interlink between ICSR and IDMP will be discussed at length.
Professionals involved in:
At the conclusion of this meeting, participants should be able to:
Double Tree by Hilton Washington, Silver Spring, MDA limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until November 7, 2012, or until room block is filled). Attendees must make their own hotel reservations.
Standard Room Rate $169
Address: 8728 Colesville Road, Silver Spring, MD 20910 Phone: +1.301.589.5200
The most convenient airport is the Ronald Reagan Washington National airport and attendees should make airline reservations as early as possible. Please monitor www.diahome.org for hotel information.
Elizabeth Espich, Customer Service Associate
Agenda and Event DetailsMelissa Matta, Content LeadPhone +1.215.442.6158Fax +1 215.442.6199Melissa.Matta@diahome.org
Ellen Diegel, Event PlannerPhone +1.215.293.5810Fax +1.215.442.6199Ellen.Diegel@diahome.org
Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102.As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer 0.9 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.These programs are part of DIA’s Certificate Program and are awarded the following.• Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units eachFor more information go to www.diahome.org/certificateprograms
It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.
If you would like to receive a statement of credit, you must attend the program (and tutorial, if applicable), sign-in at the DIA registration desk each day of the program and/or tutorial, and complete the on-line credit request process through My Transcript at www.diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on December 14, 2012.To view DIA’s Grievance Policy, please visit the CE page on DIA’s website at www.diahome.org
Business Lead, EudraVigilance and International Standardisation in PhVEuropean Medicines Agency, European Union, United Kingdom
Hepatologist, Pharmacovigilance ExpertGLD Conseil, France
Senior Director, Worldwide Safety and RegulatoryPfizer, Inc., United States
Senior Regulatory Program Management Officer, OD, CBER FDA, United States
Project Manager, Bioinformatics Support Staff, CBER FDA, United States
CANCELLATION POLICY: All cancellations must be received in writing two weeks before the start of the event. Administrative fee that will be withheld from refund amount:
Cancellations must be in writing and be received two weeks before the start of the event. Registrants who do not cancel two weeks before the start of the event and do not attend the event will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel and airline reservations. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.
Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.