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Premarketing Clinical Safety and Pharmacovigilance

Mar 10 2014 8:00AM - Mar 11 2014 4:00PM | DIA 800 Enterprise Rd Ste 200 Horsham, PA 19044

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Overview 

Learn how to comply with evolving US and European regulations for clinical safety during product development that are changing how we approach our daily jobs.

Course Level: Intermediate

What You Will Learn 

  • Fundamental concepts of clinical drug safety and pharmacovigilance and their application to clinical development, with a focus on traditional small molecules
  • How to avoid common pitfalls in complying with FDA and European clinical safety regulations
  • What to expect in a preapproval safety inspection
  • Proven concepts of premarketing risk assessment and their important role in drug development
  • How to effectively use signaling tools and techniques to support premarketing risk assessment

Who Should Attend 

Professionals involved in:

  • Clinical safety and pharmacovigilance
  • Clinical development, including sponsors and investigators
  • Regulatory affairs
  • Quality management
  • Clinical data management

Learning Objectives 

At the conclusion of this activity, participants should be able to:

  • Discuss why premarketing clinical safety and pharmacovigilance are important to ensure Good Pharmacovigilance Practice
  • Explain the key requirements and differences in FDA and European regulations for premarketing clinical safety and pharmacovigilance
  • Explain concepts of a preapproval clinical safety inspection
  • Develop company policies and procedures for clinical safety
  • Explain how premarketing risk assessments are performed

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 February 23, 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 Details 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 

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; +1.703.506.3275.

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 1.4 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.

CERTIFICATE PROGRAMS

These programs are part of DIA’s Certificate Program and are awarded the following:
• Clinical Safety and Pharmacovigilance Certificate Program: 8 Core Units

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

Name Credit Type Max Credits CEU
Premarketing Clinical Safety and Pharmacovigilance IACET 14.25 1.400

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 course, sign-in at the DIA registration desk each day of the course, and complete the on-line credit request process through 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, two weeks after the last day of the course.

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
$810.00
Member Government
$810.00
Member Standard
$1475.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$1035.00
NonMember Government
$1035.00
NonMember Standard
$1700.00
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

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.

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