Showing posts with label EU regulatory. Show all posts
Showing posts with label EU regulatory. Show all posts

Thursday, April 18, 2013

Speak at the EuroMeeting 2014


 
26th Annual EuroMeeting 2014
March 25-27 | Vienna, Austria
Abstract submission deadline: May 29

Submit your presentation, session or tutorial abstracts for DIA’s Annual EuroMeeting and share your research with more than 3,000 professionals from around the world.

Session Abstract
A session abstract is a 90-minute session concept delivered lecture-style from the podium. The abstract author is considered the session chair and will coordinate efforts in recruiting speakers and manage the session. PowerPoint presentations are required. We welcome innovative ideas for session formats that will enhance interaction between stakeholders.

Presentation Abstract
A presentation abstract is for a 20-minute presentation in a specific topic area. The abstract author is considered the speaker and a PowerPoint presentation is required.

Tutorial Abstract
A tutorial is a ‘hands-on’, interactive learning experience. A tutorial consists of three hours of instruction with a 30-minute break halfway through. The abstract author is considered the instructor. One co-instructor may be recruited but cannot be from the same company/organization as the author.

To give your session, presentation or tutorial abstract the best chance of being accepted focus on the programme themes.

Hot-Topic/Stand-Alone Sessions
Each year, there are a number of sessions that do not fit directly under the programme themes. If your abstract clearly does not fit with any of the themes/topics outlined, you may submit it for consideration as a hot-topic/stand-alone presentation/session.





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Wednesday, April 17, 2013

Webinars: Important Updates on New European Pharmacovigilance Requirements


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Important Updates on New European Pharmacovigilance Requirements
Presenters:
    • Stella C.F. Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
       EMA Risk Management Development and Scientific Lead, European Medicines Agency
    • Joanna Faith Haas, MD, MSc, FACPM, FISPE, Founding Partner, Haas and Partners
    • Steve Jolley, MA, Principal, SJ Pharma Consulting
With the new European Pharmacovigilance legislation that went into effect in July 2012, implementation is ongoing. Hear from global experts on the impact of the new Pharmacovigilance legislation and important updates since the legislation went into effect.
Does your company understand the processes to perform adequate Benefit-risk assessment?
Your product could suffer significant consequences if your company does not have the proper systems and processes in place. In just two 90-minute sessions you will gain a better understanding of how to work to meet EU standards and become better prepared to implement regulatory requirements for signaling and risk management.
Featured Topics:
    Part One:
    • EU Regulatory Framework
    • Ongoing Timeframe for Implementation of the New Legislation
    • GVP Modules and Implementing Measures
    • PV System Master File (PSMF)
    • Audit and Inspection
    • ADR Reporting
    • The Pharmacovigilance Risk Assessment Committee (PRAC)
    Part Two:
    • Risk Management Plans: Risk Assessment and Risk Minimization
    • Periodic Safety Update Reports (PSUR)/ Periodic Benefit-risk Evaluation Report (PBRER)
    • Signal Management
    • Post Authorization Studies of Safety (PASS) and Efficacy (PAES)
    • Implications for International Harmonization
    • And More...
You’ll Learn:
    • New EU regulatory requirements for drug safety
    • How to process adverse events to meet EU requirements
    • What to expect in a European Pharmacovigilance inspection
    • Differences between the old PSUR and the new PBRER
This is the webinar your entire Pharmacovigilance team cannot afford to miss.
Who Should Attend?
Professionals involved in:
     • Drug Safety and Pharmacovigilance
     • Regulatory Affairs
     • Clinical Development
     • Benefit-risk Management
• Executives (Including C-Level) with Any Legal
   Responsibility for Drug Safety
• Market Access
• Post-approval Studies
Did You Know?
You can receive 1 elective unit towards your Clinical Safety and Pharmacovigilance Certificate by attending this webinar.
April 18 | 11:00AM-12:30PM ET
April 24 | 11:00AM-12:30PM ET
April 30 | 12:30-2:00PM ET



Sign up for DIA's Global SmartBrief: Break through the information clutter with FREE, twice-weekly email publication that gives quick, easy-to-read summaries of articles relevant to you. Get the latest news in drug development innovations worldwide wherever you are on your laptop or smart phone with SmartBrief’s wireless compatibility.

Tuesday, March 5, 2013

What's on tap for final day of EuroMeeting2013? March 6, Amsterdam

EuroMeeting2013
RAI
Amsterdam