Showing posts with label Eudravigilance. Show all posts
Showing posts with label Eudravigilance. Show all posts

Tuesday, April 23, 2013

What are the new international standards and terminologies for reporting to EudraVigilance?

Highlights of the New Pharmacovigilance Legislation in the EU: Key Pointsto be Taken into Account for Successful Implementation and Lessons Learned
June 23 from 1:00PM – 4:30PM in Boston


 This tutorial will focus on the impact of the changes in relation to the new reporting rules and requirements as set out in the Commission’s Implementing Measures and the GVP Modules and the big impact on the operational procedures and the day to day activities of stakeholders. It will also highlight the strengthening of the EudraVigilance System to improve transparency, data quality and to support signal detection and management activities in the EU. In addition, specific emphasis will be placed on informing, explaining and helping stakeholders apply the new rules taking into account the international standardization and harmonization activities and data privacy challenges.

Instructor(s):
Sabine Brosch, PharmD,PhD
Business Lead, EudraVigilance and International Standardisation in PhV
European Medicines Agency, European Union, United Kingdom

Barton L. Cobert, MD,FACP
President
BLCMD Associates, LLC, United States


 What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.


 Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.
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Monday, February 4, 2013

Speaker Highlights at EuroMeeting 2013 and Pre-conference tutorials


From DIA
Speaker Highlights at EuroMeeting 2013
Guido Rasi, head of the European Medicines Agency (EMA), is just one of the A-list participants set to speak at the EuroMeeting 2013 in Amesterdam March 4-6. Professor Rasi joins more than 300 speakers, moderators and panelists who substantiate the meeting’s claim to being the most important event in the medicines development calendar.
He will co-chair the event’s Regulatory Town Hall Meeting on March 6 from 2pm-3:30pm, together with Christa Wirthumer-Hoche, Member of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), and Deputy Head, Austrian Medicines and Medical Devices Agency (AGES). This session will give attendees the chance to ask burning questions to experts about a broad range of current hot topics in the development of medicines.
Top Pre-conference Tutorials
Pre-conference Tutorials are a very effective way of getting the most out of the EuroMeeting 2013. Register for one of 16 Pre-conference Tutorials to be held on Monday, March 4, 9am-12:30pm.
Two of the most popular tutorials are outlined below:
Available with new instructors!
Tutorial 1: Highlights of the Implementation of the new Pharmacovigilance Legislation With Regard to Adverse Reaction Reporting Rules, use of new International Standards and Signal Management in Eudravigilance
Gro Laier, Deputy QPPV, Novo Nordisk A/S, Denmark
Sarah Vaughan, Pharmacovigilance Information Unit Manager, Medicines and Healthcare Products Regulatory Agency (MHRA), UK

This tutorial will focus on the impact of the changes in relation to the new reporting rules and requirements as set out in the Commission’s Implementing Measures and the GVP Modules. It will also highlight the strengthening of the EudraVigilance System to improve transparency and data quality, and to support signal detection and management activities in the EU. In addition, specific emphasis will be put on informing, explaining and helping stakeholders understand how to apply the new rules, taking into account international standardization and harmonization activities and data privacy challenges.
NEW!
Tutorial 7: The Dialogue and Negotiation Process Between Applying Company and the Paediatric Committee of the European Medicines Agency
Klaus Rose, Chief Executive Officer, KlausRose Consulting, Basel, Switzerland

No new drug or biological can be submitted for marketing authorization in the EU in adults without an agreed Pediatric Investigation Plan (PIP) or a waiver from the European Medicines Agency (EMA). The development of a pediatric strategy can be divided into three phases:
· Strategic preparation and homework
· The dialogue and negotiation procedure with the Pediatric Committee (PDCO) of the EMA
· Follow-up activities including performing agreed studies and other measures, PIP modification(s), and compliance check by EMA
This tutorial will focus on the dialogue and negotiation procedure during its different stages, from the submission of the initial letter of intent to the adoption of the final PDCO position. It will present key learnings on frequently encountered difficulties or misunderstandings from EMA/PDCO and applying companies. The tutorial will be as interactive as possible and should help attendees reduce avoidable misunderstandings in the future.
Download the most current version of the Conference Programme and read about all the themes, sessions, exhibition and other activities the EuroMeeting has to offer.
To find out more or to register visit the EuroMeeting 2013 website.
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Friday, February 1, 2013

Professional development - Tutorials at EuroMeeting2013 4 March in Amsterdam


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