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The Impact of Drug Shortages on the Pharmaceutical Industry Part 3: Coordination and Communication with FDA and Worldwide Regulatory Authorities Regarding Manufacturing and Drug Shortage Issues

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Overview 

Continuing Education Credits or Certificate Program units are not available for Archive Webinars.


FDA, drug manufacturers, and legal experts will discuss best practices for interacting with regulatory authorities to address drug shortage issues. Best practices regarding handling an FDA inspection and the enforcement landscape of FDA’s regulation of drug manufacturing will also be discussed.

Archived Webinar available through May 29, 2013.

Who Should Attend 

Manufacturers, Distributers, Purchasing Organizations, Regulatory Bodies and Policy Makers:

  • Regulatory Affairs
  • Clinical Safety/Pharmacovigilance
  • Pricing/Reimbursement
  • Public Policy/Law/Corp. Compliance
  • Quality Assurance/Quality Control
  • Strategic Planning
  • Sales and Marketing

Learning Objectives 

Participants who complete this webinar should be able to:

  • Discuss best practices for interacting with regulatory authorities to address drug shortage issues
  • Describe the enforcement landscape of FDA’s regulation of drug manufacturing
  • Explain best practices regarding handling FDA inspections

 

Special Offers 

Save up to 20 percent by registering online in one transaction for multiple webinars in this series. (Special pricing valid for online registrations by individuals and groups.)

Contact Information 

Questions on Archived Webinars
Carolyn Callahan
DIA North America
Phone +1.215.442.6194
Fax +1.215.442.6199
Carolyn.Callahan@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Wednesday, May 30, 2012

  • 7:00AM - 11:59PM

    The Impact of Drug Shortages on the Pharmaceutical Industry Part 3: Coordination and Communication with FDA and Worldwide Regulatory Authorities Regarding Manufacturing and Drug Shortage Issues

    Speaker(s):

    • Ilisa B.G. Bernstein, JD,PharmD
      Acting Director, Office of Compliance, CDER
      FDA, United States
    • Coordination and Communication with FDA and Worldwide Regulatory Authorities Regarding Manufacturing and Drug Shortage Issues
      Steven Lynn, MSc
      Director (acting), Office of Manufacturing and Product Quality, OC, CDER
      FDA, United States
    • Pharmaceutical Production Scheduling During Times of Drug Shortages
      Jonathan Kafer
      Vice President, Sales and Marketing
      Teva Pharmaceuticals, United States
    • David Gaugh, RPh
      Senior Vice President for Sciences and Regulatory Affairs
      Generic Pharmaceutical Association (GPhA), United States
    • Best Practices for FDA Interactions During Drug Shortages
      Nathan Sheers
      Partner
      Sidley Austin LLP, United States

Registration Fees 

Other Fees

Government (Full Time) Individual
$125.00
Charitable Nonprofit/Academia Individual
$175.00
Group Site
$799.00
Group Plus
$995.00

Member

Member Individual
$250.00

Non-Member

NonMember Individual
$295.00
Register Online
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