EU Pharma IMPACTS

Publication Date	August 2005
Publisher	Jouhou Koukai
Product Type	Newsletter
Pages	90
ISBN Number	not applicable
Product Code	JOU00002

Price

£450.00
approximately: $656 | €519

PDF

Order above formats by FAX

Summary

The EU Pharma Impacts is an innovative information source designed to provide readers with analytical updates on the changing landscape of EU regulations for medicinal products and medical devices in an expert-produced and easy to grasp one-page format with special emphasis on the implications for the pharmaceutical and medical device industries. Key features of EU Pharma Impacts are:

Written by experts on EU pharma and pharmaceutical affairs having among them a former head of a National Medicines Agency, executives from European pharmaceutical industry trade organizations and pharma researchers
EU Pharma Impacts content is designated for both customers in the key regulatory regions like North America and Japan, and for users across the enlarging European Union
Each release of the EU Pharma Impacts contains a characteristic highlighted text box describing the impact on the pharmaceutical industry - expected to results from the newly introduced requirements, decisions and activities in the EU
EU Pharma Impacts reflect published documents, statements and press releases by European Medicines Agency (EMEA), European Commission (especially F2 Unit "Pharmaceuticals" at DG "Enterprise and Industry"), European Council, European Court of Justice, European Directorate for Quality of Medicines (EDQM), and other relevant EU bodies
EU Pharma Impacts are accompanied by mini English-language Glossary of the terms and definitions related to the EU pharmaceutical affairs
Additional value-added features are the summaries of otherwise quite lengthy documents, list of the targeted professionals, current and future legal status of the document, links to the original sources and thumbnail of the documents.

Together these solutions help the pharmaceutical professionals outside EU to keep abreast with the key developments and their potential implications.

Content

January 2005
- - First EU Guideline on Novel and Established Vaccines Adjuvants
- - EU Clinical Trial Guideline on Obsessive Compulsive Disorder Medicines
- - EU Clinical Trial Guideline on Panic Disorder Medicines
- - EU Clinical Trial Guideline on Generalized Anxiety Disorder Medicines
- - New Requirements for HRT Clinical Trials
February 2005
- - EU Committee for Orphan Medicinal Products Report Six New Designations
- - EU Guideline on Quality of Inhalation and Nasal Products
- - The EMEA Updated Q&A Document on COX-2 Inhibitors
- - Guideline on Pharmacokinetics in Patients with Impaired Hepatic Function
- - EU Draft Guideline on Delivery Devices for Liquid Forms
- - EU Clarifies what Is "Serious Risk to Public Health"
March 2005
- - Guidance on Grounds for Inspections at Active Substance Manufacturers
- - EU Is Concerned on Safe and Efficacious Co-administration of Tenofovir and Didanosine
- - Seven New Designations for Orphan Medicines in the EU
- - First Revision of Core SPC for Human Albumin in the EU
- - Guideline on Quality Aspects of Biosimilar Products
April 2005
- - The European Court of Justice Questions the Food Supplement Rules in the EU
- - Pfizer Suspended the Use of Bextra (Valdecoxib) in the EU
- - Nine New Designations for Orphan Medicines in the EU
- - EU Introduce Braille Requirements for Labeling and the Package Leaflet
- - EU Guideline on Clinical Trials in Small Populations
- - EU Will Review Serious Skin Reactions in All COX-2 Inhibitors
- - Potential Cancer Risk in Tacrolimus and Pimecrolimus
- - Antidepressants in children and adolescents reviewed
May 2005
- - CHMP Monthly Report of April 2005
- - EU Guideline on Non-Clinical Investigation of the Drug Dependence Potential
- - Advanced Therapies Regulation under Preparation in EU
- - How HMPC Will Work on EU Herbal Draft List and Monographs
- - How HMPC Will Appoint Experts and Offer Expert Advice
- - EU view on Herbals Containing Capsicum / Capsaicin, Asarone, Pulegone and Menthofuran
- - EU View on Allergic Potency of Chamomilla and Soya or Peanut Protein
- - Post-menopausal Osteoporosis Guidance to Be Revised
June 2005
- - EMEA Finalizes New Procedure for EU Pharmaceutical Guidelines
- - EMEA Concludes Action on COX-2 Inhibitors