aemps.gob.es
Agencia Española de Medicamentos y Productos Sanitarios - La AEMPS - Enlaces de interés de la AEMPS
http://www.aemps.gob.es/enlaces/home.htm
Enlaces de interés de la AEMPS. Uacute;ltima actualización: 22/03/2016. Agencias de Evaluación de Medicamentos. Grupos de interés. Agencias de Evaluación de Medicamentos. HMA – Heads of Medicines Agencies. Alemania – BfArM, Federal Institute for Drugs and Medical Devices. Alemania – PEI, Paul-Ehrlich-Institut. Austria – Austrian Medicines and Medical Devices Agency. Bélgica – Federal Agency for Medicines and Health Products. Bulgaria – Bulgarian Drug Agency. Bulgaria – National Veterinary Service. Narodo...
pharmdevgroup.com
International Health Authority's Websites - PDG
http://www.pharmdevgroup.com/regulatory-resources/international-health-authoritys-websites
Strategic Drug Development Services. Pharmaceutical Development Programs: Implementation and Oversight. Investigational New Drug Application (IND)/Special Protocol Assessment (SPA). Pre-NDA Meetings and NDA Submissions: 505(b)(1)/505(b)(2). Generic Drugs: 505(j) ANDAs and Potential Diversification. Exempt Devices / 513(g) Submissions. Device Pre-submission Meetings and Reviews. Combination Device and Drug/Biologic Submissions. Quality Assurance & Compliance. Scientific and Technical Writing. Finland R...
eurepresentative.com
The European Union | I.D.E.A. Ltd. - Innovative Drug European Associates
http://www.eurepresentative.com/about-us/the-european-union
How to work together with us. Download EU legal Documents. We enable non-EU sponsors to perform clinical research in the European Union. How to work together with us. Don't fill this field! IDEA can represent you in all 28 countries of the European Union. Click on a flag below to open the Competent Authority website for that Member State. Phone: 44 (0) 203 036 0764. E-mail: info@EURepresentative.com. Phone: 49 (0) 89 7801666-10. E-mail: info@EURepresentative.com.
toprasymposium.org
About the MedDev Symposium
http://www.toprasymposium.org/TOPRA/Symposium/About_the_MedDev_Symposium.aspx
Skip to main content. Regulatory challenges today and tomorrow. Annual Medical Devices Symposium. 29-30 September 2016, Amsterdam. Organised in conjunction with the Medicines Evaluation Board. The agenda goes far beyond the basics and provides an ideal platform for significantly improving your knowledge on the issues that matter, as well as offering extensive networking opportunities with your peers and colleagues. Therapies of the future? How can digital health enable better patient outcomes?
toprasymposium.org
About the Symposium
http://www.toprasymposium.org/TOPRA/Symposium/About_the_Symposium.aspx
Skip to main content. Regulatory response to public health needs. 28-30 September 2016, Amsterdam. Organised in conjunction with the Medicines Evaluation Board. The TOPRA Annual Symposium is a vibrant forum where you’ll hear about the latest issues affecting your regulatory role. Expect in-depth analysis of current issues and practical solutions to prepare you for future developments. Addressing public health needs, a Dutch perspective. Multi-annual work plan of the Heads of Medicines Agencies (HMA).
toprasymposium.org
About the Vet Symposium
http://www.toprasymposium.org/TOPRA/Symposium/About_the_Vet_Symposium.aspx
Skip to main content. Regulation, Availability and Innovation! 11th Annual Veterinary Medicines Symposium. 28-29 September 2016, Amsterdam. Organised in cooperation with the Medicines Evaluation Board. Updates on the new legislation. Animal health needs and regulatory methods to address these. Focus on the Ecotoxicology Section of the Dossier. Progress with novel therapies. Practical session on regulatory changes in the last year. Chair) RA-Elect Ltd, UK. Ceva Santé Animale, France. 44 (0) 20 7510 2560.
toprasymposium.org
About home - Human medicines
http://www.toprasymposium.org/Symposium/About_Symposium/TOPRA/Symposium/About_home.aspx?hkey=8ad7487f-71c9-46c3-b767-f845ce07f701
Skip to main content. Regulatory response to public health needs. Programme at a glance. DAY 1: 28 September. TOPRA Annual Lecture 2016: Addressing public health needs A Dutch perspective. Dr M T (Marcel) van Raaij. Department of Pharmaceutical Affairs and Medical Technology of the Ministry of Public Health and Sport, The Netherlands. Session 1: The HMA Multi-Annual Plan. Speakers including Dr Ian Hudson. Session 2: Orphan Drugs and Paediatrics major changes or minor updates? DAY 2: 29 September. Session...
