Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum
Aug 12 2013 8:00AM - Aug 14 2013 4:30PM | Omni Parker House
60 School Street,
Boston, MA 02108
This basic to intermediate-level course focuses on pharmacovigilance of traditional medicinal products intended for human use. Topics will span investigational and marketed products in clinical trials, postmarketing studies, and under conditions of actual use in real-world health care settings. Late breaking regulatory changes, pertaining to the EU will be presented.
What You Will Learn
- Legal basis for safety reporting including a historical perspective
- Basic definitions and tools
- Evaluation of seriousness, expectedness, and causality
- Safety reporting requirements in the premarketing phase
- Data collection, processing, and requirements in the postmarketing phase
- Case studies and practical exercises
- Active safety surveillance in the postmarketing phase
- Audits and inspections
- Introduction to signal detection and risk assessment
- Basics of risk management in the US and EU
- Principles of pharmacoepidemiology
Who Should Attend
Professionals working in pharmaceutical industry, academia, and drug regulatory authorities with basics to intermediate level experience in:
- Clinical safety/pharmacovigilance
- Medical writing
At the conclusion of this activity, participants should be able to:
- Identify the history, principles, and regulatory framework for clinical drug safety
- Discuss the basic definitions of terms used in day-to-day pharmacovigilance work
- Recognize basic international regulatory requirements for safety surveillance, as well as those requirements specific for the US and EU
- Describe the criteria and elements of expedited and periodic reporting of drug safety from first in human studies through the postmarketing phase
- Demonstrate an awareness of risk management principles and pharmacoepidemiology
Group Discounts Available! Register 3 and Get the 4th FREE!
Hotel & Travel
Omni Parker House
A limited number of rooms are available at the reduced rate shown below (DIA is guaranteed until July 26, 2013, or until room block is filled). Attendees should make airline and room reservations as soon as possible.
Address: 60 School Street, Boston, MA 02108
Standard Room Rate
When making reservations, mention the DIA training course.
Click here for The Omni Parker House.
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 22.75 contact hours or 2.275 CEUs. Type of Activity: Knowledge UAN: 286-0000-13-027-L04-P (Day 1), 286-0000-13-028-L04-P (Day 2) and 286-0000-13-029-L04-P (Day 3)
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 2.3 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.
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Safety and Pharmacovigilance Certificate Program:16 Core Units
For more information go to www.diahome.org/certificateprograms
|Pragmatic Approaches to Drug Safety Across the Pre
|Pragmatic Approaches to Drug Safety Across the Pre
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 course, sign-in at the DIA registration desk each day of the course, 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 two weeks after the last day of the course.
Please note: If you do not sign-in, you will not receive CE credit as a partial credit will not be awarded.
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
- Member Standard (As of 07/23/2013)
- Charitable Nonprofit/Academia Nonmember
- NonMember Government
- NonMember Standard
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.
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.