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Find An Educational Offering
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10025 Global Approach to the Risk Management of Medicines
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Title:
Global Approach to the Risk Management of Medicines
Date(s) And Time(s):
Sep 30 2010 8:00AM - Oct 1 2010 4:00PM
Location:
Washington Marriott Hotel
1221 22nd Street NW
Washington, DC 20037-1294
Overview:
Join Authorities, Global Regulators, Industry Representatives, and Marketing Application Holders for an Interactive Discussion of RMPS.
This conference will teach you how to identify and organize essential components of RMPs as they apply to medicinal products, therapeutic biologics, and vaccines. Experts speakers will focus on well-described risks, poorly understood risks, and certain potential risks of products, which may be made available to patients and healthcare providers in different regions of the world.
Featured Topics
• Why risk management plans (RMPs) are important to your organization from a global regulatory perspective
• Pros and cons of a global vs. local approach to developing RMPs
• How an harmonized RMP can promote efficient, evidence-based decision-making to support the best use of marketed products and thereby enhance public health
• How to develop an harmonized approach to creating an RMP
Learning Objectives:
At the conclusion of this meeting, participants should be able to:
• Discuss the fundamental aspects of RMPs as applied to medicinal products, therapeutic biologics, and vaccines
• Recognize similarities and differences in RMP requirements in several regulatory jurisdictions, including Canada, the European Economic Area, Japan, and the US
• Discuss the role of RMPs from the perspective of marketing authorization holders, regulatory authorities, and other stakeholders
Target Audience:
Professionals with a basic to intermediate experience in pharmacovigilance and risk management and who are responsible for:
• Developing and evaluating RMPs
• Generating and assessing drug safety signals
• Organizing post-authorization safety studies
Event Code:
10025
Contact Information:
Contact JoAnn Boileau, Program Manager, Phone +1.215.442.6175, Fax +1.215.442.6199, or email JoAnn.Boileau@diahome.org
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CME: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine (PIM) and the Drug Information Association. PIM is accredited by the ACCME to provide continuing medical education for physicians.
PIM designates this educational activity for a maximum of 13.5 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
IACET: Drug Information Association has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA 22102; (703) 506-3275.
Drug Information Association is authorized by IACET to offer 1.4 CEUs for this program.
| Global Approach to the Risk Management of Medicine | CME
IACET
| 13.50
1.40
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0.100
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Disclosure Policy:
It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosures 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, 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.
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The most convenient airport is Ronald Reagan National Airport and attendees should make airline reservations as early as possible to ensure availability. The Washington Marriott Hotel is holding a block of rooms at the reduced rate below until September 8, 2010, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.
Single $239 Double $239
Please contact the Washington Marriott Hotel by telephone at +1.202.872.1500 and mention the DIA event. The Washington Marriott Hotel is located at 1221 22nd Street, NW, Washington, DC 20037, USA.
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Meeting
| Member Standard | $1460.00 | | NonMember Standard | $1600.00 | | Charitable Nonprofit/Academia Member | $740.00 | | Charitable Nonprofit/Academia Nonmember | $880.00 | | Member Government | $375.00 | | NonMember Government | $515.00 |
Group Discounts:
GROUP DISCOUNTS* Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 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, please make a copy of this 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.
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