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Pharmacovigilance and Global Harmonization Updates

Jul 24 2014 10:00AM - Jul 24 2014 11:30AM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)


In this webinar, speakers from Japan, Europe and the US will explore how various ICH regions are working to implement global harmonization practices in the areas of drug safety and risk management.  While many concepts of pharmacovigilance are now shared globally, regional interpretations of those concepts can vary.  The speakers will explore the implications of differences in reporting formats, clinical trial reporting requirements, and the lack of standardization of label safety information.  They will also discuss the challenges associated with implementing and adopting global harmonization practices within a company.  Finally, they will explore how the expansion of ICH is expected to benefit industry, regulators and patients and how this expansion will help to promote faster access to innovative medicines across the globe.

Who Should Attend 

Intermediate to Advanced Clinical Safety Professionals who are involved in:

  • Drug Safety/Pharmacovigilance
  • Risk Management
  • Medical Product Safety Assessment
  • Regulatory Affairs
  • Clinical Research
  • Data Analysis
  • Pharmacoepidemiology
  • Medical Information
  • Health Outcomes

Learning Objectives 

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

  • Describe harmonization efforts, updates and legislation within the EU, US and Japan
  • Discuss the challenges and implications of adopting global harmonization strategies within an organization
  • Explain how the expansion of ICH participation is expected to benefit patients and improve their access to innovative medicines and therapies

Contact Information 

Printable Registration Form

Registration Questions and Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details
Rachel Minnick, Content Lead
Phone +1.215.442.6131
Fax +1.215.442.6199
Rachel.Minnick@diahome.org

Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Faculty Or Speakers 

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Continuing Education 

The Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

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 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.

DIA’s Certificate Program Statement
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 1 Elective Units
• Clinical Safety and Pharmacovigilance Certificate Program: 1 Elective Units
• Regulatory Affairs Certificate Program: 1 Elective Units>
For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Pharmacovigilance and Global Harmonization Updates IACET 1.50 0.200

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 participate in the live webinar, and complete the 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 on Thursday, August 7, 2014.

Continuing education credits are available to learners who participate in the live webinar. Continuing education credits are not available for participation in the archived version of the webinar.

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$1499.00

Member

Member Government Individual
$125.00
Charitable Nonprofit/Academia Member Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
Charitable Nonprofit/Academia Nonmember Individual
$175.00
NonMember Individual
$350.00
Registration Information

Printable Registration Form

  • Individual registration is a license for ONE internet login allowing one viewer.
  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


Cancellations:  No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

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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