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Postmarketing Drug Safety and Pharmacovigilance

Oct 20 2014 8:00AM - Oct 21 2014 4:45PM | DIA 800 Enterprise Rd Ste 200, Horsham, PA 19044-3509 USA

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Overview 

Learn the key tools available for pharmacovigilance, discuss their uses, and consider the future directions of the field. Gain knowledge of latest changes in the US and EU regulations and best practices will be discussed.  You will gain a detailed understanding of the requirements and procedures that must be performed in order to remain in full compliance with legal obligations.

Course Level: Intermediate

What You Will Learn 

  • How to make your pharmacovigilance program more efficient and compliant
  • US, European, and other global requirements and standards in drug safety and pharmacovigilance
  • Privacy, information technology, and data protection issues involved in drug safety
  • How to speak the language of drug safety, signaling, risk management and pharmacovigilance
  • Future of drug safety and pharmacovigilance
  • The basics of drug safety inspection

Who Should Attend 

Professionals who work in:

  • Global drug safety, pharmacovigilance, and risk management
  • Regulatory and legal affairs
  • CROs, start-ups, small companies, generic drug companies and anyone needing to get up to speed rapidly on the basics of drug safety and pharmacovigilance
  • Training and teaching of drug safety and pharmacovigilance
  • Clinical health care
  • New drug development
  • Outsourcing and offshoring of drug safety
  • Supervising and dealing with drug safety

Learning Objectives 

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

  • Identify the legal and regulatory basis of postmarketing drug safety and pharmacovigilance
  • Describe how your drug safety system will perform on an audit or governmental inspection
  • Explain the requirements, changes, pitfalls and risks of drug safety and pharmacovigilance, and apply the knowledge gained in your daily pharmacovigilance functions
  • Describe your company’s drug safety system and determine whether it is meeting regulatory compliance needs and requirements

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 October 5, 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 15 contact hours or 1.5 CEUs. Type of Activity: Knowledge
Pharmacy Credit Allocation
Day 1: 0286-0000-14-032-L04-P, 7.5 contact hours or .75 CEUs
Day 2: 286-0000-14-033-L04-P, 7.50 contact hours or .75 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).

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 1.5 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: 8 Core Units each

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

Name Credit Type Max Credits CEU
Postmarketing Drug Safety and Pharmacovigilance ACPE 15.00 1.500
Postmarketing Drug Safety and Pharmacovigilance IACET 15.00 1.500

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
$810.00
Member Government
$810.00
Member Standard
$1375.00
Member Standard (As of 09/30/2014)
$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

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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