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Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum

Apr 2 2014 8:00AM - Apr 4 2014 4:30PM | DIA 800 Enterprise Rd Ste 200 Horsham, PA 19044

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Overview 

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.  Attendees will gain a detailed understanding of safety and pharmacovigilance obligations and best practices.

Course Level: Intermediate

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 basic to intermediate level experience in:

  • Clinical safety/pharmacovigilance
  • Medical writing
  • Marketing

Learning Objectives 

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

Special Offers 

Group Discounts Available! Register 3 and Get the 4th FREE!

Hotel & Travel 

Training Course Location
DIA 
800 Enterprise Road, Suite 101
Horsham, PA 19044

Hotel Information
Staybridge Suites Philadelphia- Montgomeryville
119 Garden Golf Blvd    
North Wales ,  PA   19454
Phone +1-215-393-8899
Fax +1-215-393-8898

A limited number of rooms are available at the reduced rate shown below (DIA is guaranteed until March 18, 2014 or until room block is filled). Attendees should make airline and room reservations as soon as possible.  When making reservations, mention the DIA training course.

Standard Room Rate  $109
Click here for more hotel information

Contact Information 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda and Event Logistics
Colleen Buckley, Event Planner
Phone +1.215.442.6108
Fax +1.215.442.6199
Colleen.Buckley@diahome.org

Faculty 

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Continuing Education 

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
Pharmacy Credit Allocation
Day 1: 0286-0000-14-029-L04-P, 8 contact hours or .8 CEUs
Day 2: 286-0000-14-030-L04-P, 7.75 contact hours or .775 CEUs
Day 3: 286-0000-14-031-L04-P, 7 contact hours or .7 CEUs

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 (703) 506-3275.

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 each

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Pragmatic Approaches to Drug Safety Across the Pre IACET 22.75 2.300
Pragmatic Approaches to Drug Safety Across the Pre ACPE 22.75 2.275

Disclosure Policy:

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 activity, sign-in at the DIA registration desk, 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. My Transcript will be available for credit requests two weeks after the last day of the activity.
Please note: If you do not sign-in, you will not receive CE credit as 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

Registration Fees 

Member

Charitable Nonprofit/Academia Member
$1000.00
Member Government
$1000.00
Member Standard
$1820.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$1225.00
NonMember Government
$1225.00
NonMember Standard
$2045.00
Group Discounts

Printable Registration Form

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.

Register Online

Cancellations: Cancellations must be received two weeks prior to the first day of the course. A $200 administrative charge will be deducted from the original registration fee. Cancellations must be in writing and received in the DIA office according to the timeline above. There will be no refund if cancellation is received within two weeks from the first day of the course. Registrants are responsible for cancelling their own hotel and travel reservations. Registrants who do not cancel prior to the course and do not attend will be responsible for the full registration fee. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for airfare, hotel or other costs incurred by registrants.

Transfers: You may transfer your registration to a colleague at any time but membership is not transferable. Please notify the DIA North American office of such transfers in writing as soon as possible. Substitute registrants will be responsible for the nonmember fee, if applicable.

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.

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