Navigation Links
FDAnews announces Third Annual Pharmaceutical Labeling Summit
Date:9/19/2012

FALLS CHURCH, Va., Sept. 19, 2012 /PRNewswire-iReach/ -- Third Annual Pharmaceutical Labeling Summit:

(Photo: http://photos.prnewswire.com/prnh/20120919/CG77389)

**Presented by  FDAnews**

Oct. 16-17, 2012 – Bethesda, MD

www.PharmaLabelingSummit.com

FALLS CHURCH VA USA – MEDICAL INDUSTRY EMAIL NEWS SERVICE (TM) – Sept. 17, 2012

Labeling remains one of the most intense negotiations that industry has with the FDA — whether it's the battle of getting a label approved or conflicts over postmarket revisions.

Join an elite group of drug and biologic industry executives, FDA officials, industry attorneys and thought leaders to discuss and debate the future and implications of the ongoing tug-of-war that is pharmaceutical labeling and revision.

2012 Highlighted Speakers Include:

  • Carla Cartwright, Associate Chief Counsel, Office of the Chief Counsel, FDA (invited)
  • Lonnie Smith, Project Manager, FDA Data Standards Council, CDER
  • Denise Esposito, Deputy Director, Office of Regulatory Policy, CDER, FDA (invited)
  • Dr. Mark Collins, Director, Pharmacovigilance and Risk Management, Endo Pharmaceuticals
  • Virginia Hogan, Associate Director, Labeling, Teva Pharmaceuticals
  • Steffen Johnson, Partner, Winston & Strawn
  • Dr. Michael Ryan, Department of Psychology, The University of Texas at San Antonio
  • Jim Beck, Partner, Reed Smith
  • Mona Desai, Manager, Labeling, Regulatory Affairs, Interchem
  • Randall Christian, Partner, Bowman and Brooke

Who Should Attend:

  • VP/Director Global Labeling 
  • Global Regulatory Affairs
  • Promotional Regulatory Affairs
  • Regulatory Affairs Labeling
  • Labeling and Product Communications
  • Scientist, Regulatory Affairs
  • Chief Regulatory Counsel
  • Chief Medical Officer
  • VP/Director Global Patient Safety
  • Corporate Counsel
  • Outside Counsel

Register today

AGENDA
Tuesday, October 16, 2012
8:00 a.m. – 9:00 a.m.  Registration and Continental Breakfast
9:00 a.m. – 9:15 a.m.  Chair Welcome and Introduction
9:15 a.m. – 10:00 a.m.  FDA's Expectations for Compliant Labeling in 2013 and Beyond
10:00 a.m. – 10:45 a.m.  Accessing Package Insert (Content of Labeling) Information Via Mobile Devices
10:45 a.m. – 11:00 a.m.  Morning Break
11:00 a.m. – 12:00 p.m.  Panel Discussion:  Examination of How the FDA Applies Black Box Warnings Within a Drug Class
12:00 p.m. – 1:30 p.m.  Lunch Break
1:30 p.m. – 1:45 p.m.  Recap of Morning Sessions
1:45 p.m. – 2:30 p.m.  SPL Update and Downstream Use of SPL
2:30 p.m. – 3:15 p.m.  ANDA Labeling — Current Status of the FDA's Labeling Review and Approval Process
3:15 p.m. – 3:30 p.m.  Afternoon Break
3:30 p.m. – 4:15 p.m.  Do Drug Product Labels Confirm and Correct Consumers' Medication Preconceptions?
4:15 p.m. – 5:00 p.m.  The Impact of Labeling on Advertising and Promotion
5:00 – 7:00 p.m.  Cocktail Reception and Networking
Wednesday, October 17, 2012
8:00 a.m. – 9:00 a.m.  Registration and Continental Breakfast
9:00 a.m. – 9:15 a.m.  Chair Welcome and Introduction
9:15 a.m. – 10:00 a.m.  The Tipping Point of FDA's Public Health Voice: Has the Proliferation of Warnings Diminished the Agency's Impact on Clinical Practice
10:00 a.m. – 12:30 p.m.  Panel Discussion:  Pilva v. Mensing Redux?  What Does the First Circuit Court of Appeals Decision in Barlett v. Mutual Mean for Generic Preemption?
12:30 p.m. – 1:30 p.m.  Lunch Break
1:30 p.m. – 4:00 p.m.  Panel Discussion:  Determining Threshold and Causality When Considering Label Updates — How Safety Signals, REMS and Pharmacovigilance Are Influencing Labeling Decisions
4:00 p.m. – 4:15 p.m.  Day Two Adjourn, Closing Remarks

CONFERENCE DETAILS
Third Annual Pharmaceutical Labeling Summit
**Presented by  FDAnews**
Oct. 16-17, 2012 – Bethesda, MD
www.PharmaLabelingSummit.com

TUITION:
Early Bird (Must register by Sept. 21, 2012): $1,797 per attendee 
Regular Tuition (Sept. 22-Oct. 17, 2012): $1,997 per attendee

4 Easy Ways to Register
Online: www.PharmaLabelingSummit.com
By phone: 888-838-5578 or 703-538-7600
Fax:          703-538-7676
Mail to:     FDAnews
300 N Washington St
Ste 200
Fall Church, VA 22046-3431

Media Contact: Jeff Grizzel FDAnews, 703-538-7668, jgrizzel@fdanews.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com


'/>"/>
SOURCE FDAnews
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. FDAnews announces Fourth Annual Supplier Quality Congress
2. FDAnews Announces Medical Device Mobile Apps Virtual Conference
3. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
4. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
5. JDRF Announces Research Collaboration with Dexcom, Inc. to Develop "Smart Transmitter" Technology to Accelerate Artificial Pancreas Studies
6. Misonix Announces New Distribution Agreement For Panama
7. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
8. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
9. Boston Scientific Announces CE Mark and European Launch of Emerge™ PTCA Dilatation Catheter
10. Soligenix Announces Further Progress with ThermoVax™ for Long-Term Vaccine ThermoStability
11. Masimo Announces New Low-Profile Infant and Neonatal Pulse Oximetry Sensors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2017)... 27, 2017  Sanderling Ventures, portfolio company, Torax ... division of Johnson & Johnson. Torax manufactures and markets ... of gastro-esophageal reflux disease (GERD). The LINK device ... and the procedure is currently available in the ... Medical was founded by Sanderling Ventures, Mayo Medical ...
(Date:3/27/2017)... March 27, 2017 BioLineRx Ltd. (NASDAQ/TASE: ... announced today that AGI-134, an immunotherapy for the treatment of ... Ltd., will be featured at the upcoming American Association ... Washington, DC to be held on April 1-5, ... ...
(Date:3/27/2017)... FRANCISCO , March 27, 2017 ... expected to reach USD 16.0 billion by 2025, according ... The growing prevalence of chronic diseases is anticipated to ... chemistry analyzers, which thereby widens the scope for growth ... geriatric and bariatric population, which is highly susceptible to ...
Breaking Medicine Technology:
(Date:3/27/2017)... PA and London UK (PRWEB) , ... March ... ... the speed, agility and ability to gain site attention and engagement over the ... DrugDev educational webinar will discuss how partnering with the right ...
(Date:3/27/2017)... ... March 27, 2017 , ... A study by the founder of ... colleague, Sudeep Roy, MD, was recently published in the American Journal of Cosmetic ... details Drs. Buckingham and Roy’s study on the use of Electro Lube during the ...
(Date:3/27/2017)... Arizona (PRWEB) , ... March 27, 2017 , ... Buzzies ... the top 10 for Rent the Runway Foundation and UBS’ Project Entrepreneur. Mayo will ... York on April 8. , Project Entrepreneur’s second annual venture competition ignites bold ...
(Date:3/27/2017)... IL (PRWEB) , ... March 27, 2017 , ... ... systems, recently received the CE Certificate of Conformity for the Smart System® 20/20. ... or exceed the highest industry standards and specifications such as ANSI, ISO and ...
(Date:3/27/2017)... ... March 27, 2017 , ... American ... conference coverage on veterinary medicine, announces the launch of Veterinarian’s Money Digest™, a ... with the April edition of American Veterinarian™. , “We look forward ...
Breaking Medicine News(10 mins):