Date(s) And Time(s):
Mar 14 2012 8:00AM - Mar 15 2012 5:00PM

Location:
DIA
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr...

Overview:

An In-depth Look at Practical Solutions to Postmarketing Safety and Pharmacovigilance

Learn the key tools available for Pharmacovigilance, discuss their uses, and consider the future directions of the field.

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

· The future of drug safety and Pharmacovigilance

· The basics of drug safety inspection

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.

Learning Objectives:

At the conclusion of this course, 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, applying the knowledge gained in your daily pharmacovigilance functions

· Discuss US, EU, and other countries handling of expedited reports, ICSRs, aggregate reports, safety labeling, risk management, causality determination, signaling, audits and inspections, quality, compliance, IT, basic epidemiology, and more

· Describe your company’s drug safety systems and determine whether they are meeting the needs and requirements

Target Audience:

Professionals involved 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

Event Code:
12416

Contact Information:
For registration questions, please contact Marilyn Ginsberg at (215) 442-6135 or Marilyn.Ginsberg@diahome.org
For agenda details, please contact Colleen Buckley at (215) 442-6108 or Colleen.Buckley@diahome.org