EU Commission - proposals for new Pharmaceutical Legislation
| Date | 25/02/2009 - 26/02/2009 |
|---|---|
| Venue | Radisson SAS Royal Hotel Brussels |
| Address | Brussels, Belgium |
| Reference |
Online Booking
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New Speakers and programme content confirmed for TOPRA's meeting to discuss the European Commission's Pharma Package
Safe, innovative and accessible medicines: a renewed vision for the pharmaceutical sector: European Commission adopts Communication and legislative proposals.
This will be the first opportunity for Agency and Industry discussion on these important changes, so book your place now for 25-26 February in Brussels at this meeting organised by TOPRA in cooperation with the European Commission.
As mentioned in the last newsletter, the European Commission adopted on the 10th December 2008 three legislative proposals as part of the “Pharmaceutical Package”. This covers a range of legislative changes designed to enhance the safety and availability of medicines accompanied by Communication on a vision for the pharmaceutical sector in Europe. Enhanced legislative measures covering Pharmacovigilance, Information to Patients and Counterfeit medicines are introduced. This meeting will provide an introduction to the workings of the legislative process within the European Commission, the reasons behind the Communication and the Pharmaceutical Package plus in detail the three legislative proposals of Pharmacovigilance, Information to Patients and Counterfeit medicines will be discussed.
Speakers confirmed to date include:
- Martin Terberger, Head of Pharmaceuticals unit (F2), European Commission
- Irene Sacristan Sanchez, Deputy Head of Pharmaceuticals unit (F2), European Commission
- Stefan Führing, Pharmaceuticals Unit (F2), European Commission
- Lenita Lindström-Rossi, Pharmaceuticals Unit (F2), European Commission
- Thomas Heynisch, Competitiveness in the Pharmaceuticals Industry and Biotechnology Unit (F5), European Commission
- Lisette Tiddens-Engwirda, Secretary General, Standing Committee of European Doctors (CPME)
- Christer Backman, Swedish MPA
- Ilaria Passarani, Health policy officer, BEUC, The European Consumers' Organisation Bureau, Européen des Unions de Consommateurs
- Paul Woods, AstraZeneca
- Susanne Keitel, Director, European Directorate for the Quality of Medicines and Health (EDQM)
- Heinz Kobelt, European Parallel Importers association (EAEPC)
- Steve Allen, Pfizer
- Michael Deats, Group Manager, Enforcement Group Inspection, Enforcement and Standards Division, MHRA
- Doris I. Stenver, Chief Medical Officer, Consumer Safety Division, Pharmacovigilance Working Party Delegate, Danish Medicines Agency
Plus other agency and industry speakers invited
Stakeholders from the member states, the EMEA and other interested parties are invited to attend and hear from European Commission representatives how the proposed legislative changes could affect them. Note the date of 25-26 February 2009 in your diaries for this essential meeting in Brussels. Look out for future announcements containing more details from TOPRA and the European Commission Pharmaceuticals unit over the next month.
European Commission - Pharmaceutical Package
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Counterfeit Medicines in the News (English)
Counterfeit Medicines: The Pills That Kill
The multi-billion-pound global trade in bogus medicines is responsible for an estimated half a million deaths a year. As Europe becomes an ever-more lucrative target for counterfeiters, Eric Clark meets the government agents and pharmaceutical company investigators who are taking the fight to the fakers.
Click here to read the full article.
Fake drugs worth more than £4m seized by Interpol
Fake drugs worth an estimated $6.6 million (£4.4m) have been seized and 27 people arrested in police raids across southeast Asia, Interpol has said.
Click here to read the full article.
Trio warn against counterfeit medicines
Health regulators, patient groups and the pharmaceutical industry are launching a campaign to warn consumers about thee dangers of buying fake medicines. The collaboration comes after a steep rise in the purchase of drugs online.
Click here to read the full article.
Counterfeit Medicines in the News (German)
Viagra: Zoll beschlagnahmt 600 000 gefälschte Potenzpillen
Beamte am Frankfurter Flughafen haben eine der weltweit größten Mengen gefälschter Potenzpillen sichergestellt.
Click here to read the full article.
Gefälschte Arzneien: Viagra-Kopien nehmen zu
Der Zoll beschlagnahmt immer häufiger gefälschte Potenzpillen. Aber auch illegale Diätmittel und Präparate für den Muskelaufbau werden zahlreicher.
Click here to read the full article.
EU-Kommission Gütesiegel gegen gefälschte Medikamente
In Europa kursieren immer mehr gefälschte Medikamente. Dem will die EU-Kommission nun entgegentreten.
Click here to read the full article.
Gesundheit: Immer mehr gefälschte Medikamente
Gefälschte Arzneimittel sind auf dem europäischen Markt im Vormarsch. Die Zahl an EU-Grenzen sichergestellter Medikamenten stieg innerhalb der letzten zwei Jahre um 570 Prozent.
Click here to read the full article.
Counterfeit Medicines in the News (French)
Sanofi-Aventis se dote d'un laboratoire anti-contrefaçons
Sanofi-Aventis a inauguré, jeudi 4 septembre, à Tours, un laboratoire dédié à la détection de la contrefaçon. Cet outil d'un million d'euros est en mesure d'analyser échantillons, emballages et notices en provenance de toutes les usines du groupe dans le monde.
Click here to read the full article.
Counterfeit Medicines in the News (Spanish)
Cocco establece cero tolerancia con la medicina falsificada
SANTO DOMINGO.- El director general de Aduanas, licenciado Miguel Cocco advirtió hoy que serán implacables contra los responsables del comercio de medicina falsificada y de su contrabando, para quienes decretó tolerancia cero. Tras considerar que la comercialización de medicinas falsificadas representa un daño permanente a la población, afirmó que su consumo constituye un atentado contra la vida.
Click here to read the full article.
Miguel Cocco: cero tolerancia al comercio de medicina falsificada y su contrabando
La Secretaría de Salud Pública y Asistencia Social (SESPAS) y la Dirección General de Aduanas (DGA) serán implacables y aplicarán cero tolerancia contra los responsables del comercio de medicina falsificada y de su contrabando, afirmó este miércoles el titular de aduanas, licenciado Miguel Cocco, durante el acto de donación de una gran cantidad de medicinas y equipos a Salud Pública.
Click here to read the full article.
Uno de cada 10 medicamentos que se comercializan en el mundo es falso
- El negocio de los fármacos falsos mueve más de 50.000 millones de euros
- Anabolizantes, antibióticos y antipalúdicos, entre los productos más falsificados
- Diversos organismos pedirán al Ministerio de Sanidad que tome cartas en el asunto
Click here to read the full article.
Malaria y fármacos adulterados
La presencia de medicamentos falsos es un alarmante fenómeno en aumento que afecta ya a un 10% del total de los fármacos que se emplean en el mundo, y una gran preocupación para los gobiernos y organizaciones como la OMS que luchan para ponerle freno.
Click here to read the full article.
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