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Find An Educational Offering
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10453 Drug Safety Surveillance and Epidemiology
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Title:
Drug Safety Surveillance and Epidemiology
Date(s) And Time(s):
Sep 20 2010 9:00AM - Sep 22 2010 12:00PM
Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509
Interest Area(s):
Professional Education, Training & Development,Clinical Data Management/ eClinical,Clinical Safety/Pharmacovigilance,Clinical Research,Regulatory Affairs
Overview:
Learn the Practical Side of U.S. and International Safety Surveillance
Participate in discussion on ways to apply the role of epidemiology and risk management, from both industry and FDA perspectives.
WHAT YOU WILL LEARN
· Discover the historical and regulatory framework for safety surveillance and post approval marketing
· Describe the legal and regulatory importance of safety within a drug's overall profile
· Recognize US and international safety surveillance regulatory requirements
· Describe FDA initiatives for safety surveillance of drugs, biologics and vaccines
· Apply epidemiologic methods to drug safety surveillance
· Describe the concepts, tools, and strategies for risk management
Learning Objectives:
At the conclusion of this course, participants should be able to:
- Discuss the historical and regulatory framework for safety surveillance and postapproval marketing
- Describe the legal and regulatory importance of safety within a drug’s overall profile
- Recognize US and international safety surveillance regulatory requirements
- Describe FDA initiatives for safety surveillance of drugs, biologics and vaccines
- Apply epidemiologic methods to drug safety surveillance
- Describe the concepts, tools, and strategies for risk management
Target Audience:
Pharmacovigilance professionals
Clinical development professionals
Medical affairs professionals
Event Code:
10453
Contact Information:
For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108
Email Colleen.Buckley@diahome.org
If you have not received confirmation within 5 business days, please contact:
DIA
Tel. +1-215-442-6100
Fax +1-215-442-6199
Email confirmationservices@diahome.org
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Potential faculty for this course:
Steven J. Blumenthal, MS
Director, Safety Update Reporting
Merck Research Laboratories, United States
Linda S Hostelley
Vice President, MRL Compliance
Merck & Co. Inc., United States
Judith M Sills, PharmD
Vice President and Head, Medical Safety Operations
Novartis Pharmaceuticals Corporation, United States
I. Sanford Smith, MD
United States
Annette Stemhagen, DrPH,FISPE
Senior Vice President, Safety, Epidemiology, Registries and Risk Management
United BioSource Corporation, United States
Yusuf Henriques
Interdisciplinary Scientist
FDA, United States
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ACPE: 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 activity for up to 16.75 contact hours or 1.675 CEUs. 286-000-10-015-L04-P Type of Activity: Knowledge
CME: This activity has been planned and implemented in accordance with the Essentials Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for Medicine (PIM) and Drug Information Association (DIA). PIM is accredited by the ACCME to provide continuing medical education for physicians.
Postgraduate Institute for Medicine designates this educational activity for a maximum of 16.75 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 1.7 CEUs for this program.
| Drug Safety Surveillance and Epidemiology | ACPE
CME
IACET
| 16.75
16.75
1.70
| 1.675
0.200
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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:
To receive a pharmacy statement of credit, participants must attend the program and complete the online 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.
For all physician participants who would like to receive a statement of credit, please complete the PIM evaluation and credit request form and return it to the DIA registration desk or to Colleen Buckley via fax at 215-442-6199.
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Training Course
| Member Standard | $1525.00 | | NonMember Standard | $1665.00 | | Charitable Nonprofit/Academia Member | $760.00 | | Charitable Nonprofit/Academia Nonmember | $900.00 | | Member Government | $760.00 | | NonMember Government | $900.00 |
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TRAVEL AND HOTEL INFORMATION
Hotel reservations should be made ONLY after receipt of written registration confirmation from DIA.
TRAINING COURSE LOCATION
DIA Worldwide Headquarters
800 Enterprise Road; Suite 101
Horsham, PA 19044
HOTEL LOCATION
Joseph Ambler Inn
1005 Horsham Road
North Wales, PA 19454-1413 USA
Travel Information
Tucked away on 12 acres of rolling countryside, the Joseph Ambler Inn offers the exceptional features expected of a great country inn including an award-winning Pennsylvania restaurant and 52 pampering B&B guestrooms. Surrounded by peaceful meadows and comprising 5 historic buildings, the inn’s facilities and grounds are unmatched in all of Bucks and Montgomery counties.
Just 45 minutes from Philadelphia, the Joseph Ambler Inn is centrally located to the attractions and activities of the area. Valley Forge National Park, New Hope, and Bucks County are just a one-hour drive. Day trips can be made to Atlantic City casinos, Lancaster County Amish Country, and Reading, the shopping outlet headquarters.
Hotel Information
A limited block of rooms has been reserved at the Joseph Ambler Inn at a low rate per night until the release date of September 4, 2010. We urge you to make your hotel reservations early and plan on staying at the hotel in order to facilitate interactive discussion with faculty and fellow participants.
Single $127 Double $127
Attendees must make their own hotel reservations. To reserve your room, contact the Joseph Ambler Inn by telephone at 215-362-7500 and mention the DIA Training Course.
Participants with disabilities: DIA meeting facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons attending the meeting if requested at least 15 days prior to meeting. Contact the DIA office to indicate your needs.
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