Global AE Reporting: Drug Safety Requirements in the US and EU
Nov 12 2013 8:15AM - Nov 12 2013 5:15PM | Hyatt Regency Bethesda
One Bethesda Metro Center
7400 Wisconsin Avenue
Bethesda, MD 20814-5326
This one day conference will cover intermediate-level content around the topics of collection, assessment, reporting and analysis of adverse events to meet global requirements.
Who Should Attend
Professionals involved in:
- Clinical Safety and Pharmacovigilance
- Regulatory Affairs
- Clinical Development
- Medical Affairs
- Quality Assurance
At the conclusion of this meeting, participants should be able to:
- Describe how to collect, assess, report and analyze adverse events
- Discuss US and EU regulatory requirements for drug safety and describe this impact on safety reporting
- Explain signaling analyses based on FDA and EMA requirements
- Discuss the objectives and components of a pharmacovigilance audit
- Describe the top ten findings from regulatory inspections for product safety
Hotel & Travel
Hyatt Regency Bethesda
A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until October 28, 2013, or until room block is filled). Please note: In order to receive the reduced room rate, hotel reservations must be made with Travel Planners and not directly with the hotel. Contact information for Travel Planners is as follows: Attendees can follow this link or call +1.212.532.1660 or 1.800.221.3531 in the U.S. When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #13014.
Standard Room Rate $219
Hotel Address: 7400 Wisconsin Avenue, Bethesda, MD 20814
The most convenient airport is Reagan National Airport and attendees should make both airline and hotel reservations as early as possible.
The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Drug Information Association designates this educational activity for up to 3 contact hours or .3 continuring education units (CEUs). Type of Activity: Knowledge
PHARMACY CREDIT ALLOCATION
• Session 2: Post Marketing Safety Requirements: US and EU: 1.5 contact hours or .15 CEUs; 0286-0000-13-095-L04-P
• Session 4: Signal Detection/Data Mining/Risk Assessment/Risk Management/Risk Minimization: 1.5 contact hours or .15 CEUs; 0286-0000-13-096-L04-P
ACPE CREDIT REQUEST UPDATE
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.
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 .7 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.
DIA’s Certificate Program
These programs are part of DIA’s Certificate Program and are awarded the following:
• Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
• Regulatory Affairs Certificate Program: 4 Elective Units
For more information go to www.diahome.org/certificateprograms
|Global AE Reporting: Drug Safety Requirements
|Global AE Reporting: Drug Safety Requirements
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.
Statement of Credit:
If you would like to receive a statement of credit, you must attend the program, sign-in at the DIA registration desk, and complete the on-line credit request process through DIA’s My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. 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 Tuesday, November 26, 2013.
To view DIA’s grievance policy, please visit the CE page on the DIA website at www.diahome.org/CE
- Charitable Nonprofit/Academia Member
- Member Government
- Member Standard
- Charitable Nonprofit/Academia Nonmember
- NonMember Government
- NonMember Standard
Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.
Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, print a registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.
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:
- Member or Nonmember = $200
- Government or Academia or Nonprofit (Member or Nonmember) = $100
- Tutorial (if applicable) = $50
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.