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From DIA
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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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Showing posts with label paediatric. Show all posts
Showing posts with label paediatric. Show all posts
Monday, February 4, 2013
Speaker Highlights at EuroMeeting 2013 and Pre-conference tutorials
Friday, February 1, 2013
Legal / Transparency Risk Assessment learning opportunities at EuroMeeting2013
Theme 03 - Legal/Transparency-Risk Assessment (22)
Development of Medicinal Products for Paediatric, Elderly and other sessions at EuroMeeting2013 4-6 March in Amsterdam
Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other (7)
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