Pharmaceutical Technology Europe - October 2012 - (Page 8)

NEWS BITES Potential European Pharmacovigilance Fees Criticised The European Generic Medicines Association (EGA) has raised concerns about the potential fees to be charged by the European Medicines Agency for pharmacovigilance activities. To more properly assess the proposed fee structure, EGA has suggested that the EC provides a “clear overview” of the costs associated with all of the new pharmacovigilance activities. In 2008, it was estimated that the total annual increase in fees payable to EMA would be about EUR 10.5 million ($13.7 million), but EGA estimated that the actual contributions could be more than ten times this amount. http://www.pharmtech.com/pharmtech/Online+Only/Potential-European-Pharmacovigilance-Fees-Criticiz/ArticleStandard/Article/detail/789223?contextCategoryId=35097 Novo Nordisk Expands R&D in China Novo Nordisk has invested $100 million in expanding its research centre in Beijing, China, to 12000 m2. The extra space will accommodate future growth in protein technology, biology and pharmacology research activities, fulfilling the company’s key strategic objective to develop the full range of protein research capabilities in China. The expansion will also encourage stronger contributions from the science team in China, which currently consists of 130 scientists and is expected to increase to 200 at the new site. http://www.pharmtech.com/pharmtech/News/Novo-Nordisk-Expands-RampDFacility-in-China/ArticleStandard/Article/detail/790082?contextCategoryId=35097 Eli Lilly Receives FDA Warning Letter Eli Lilly has received an FDA Warning Letter because of a “misleading” image of a multicoloured brain scan that appeared on the company’s website for Amyvid. Amyvid is indicated for PET brain scans to review β-amyloid neuritic plaque density. According to FDA, the coloured brain image classifies as misbranding because Amyvid’s product labeling states that Amyvid images must be displayed and reviewed in black and white. http://www.pharmtech.com/pharmtech/Online+Only/Eli-Lilly-Receives-FDAWarning-Letter/ArticleStandard/Article/detail/788019?contextCategoryId=35097 EMA Streamlines Working Parties The European Medicines Agency (EMA) has abolished its Cell-based Product Working Party (CPWP) and Gene Therapy Working Party (GTWP), with the aim of improving efficiencies and optimising the use of available expertise. Instead, EMA’s Committee for Advanced Therapies (CAT) will be assuming the lead role in all aspects concerning the development of advancedtherapy medicines in Europe, including developing guidelines, organising workshops and establishing ad-hoc draft groups as and when required to develop specific guidance documents. http://www.pharmtech.com/pharmtech/News/EMA-Streamlines-Working-Parties/ArticleStandard/Article/detail/790081?contextCategoryId=35097 2 OUTSOURCING 11 REGULATORY COOPERATION 7 QUALITY BY DESIGN 12 COCRYSTALS 8 NEWS 13 BLOGS 10 ENERGY EFFICIENCY 15 STAFF http://www.pharmtech.com/pharmtech/Online+Only/Potential-European-Pharmacovigilance-Fees-Criticiz/ArticleStandard/Article/detail/789223?contextCategoryId=35097 http://www.pharmtech.com/pharmtech/News/Novo-Nordisk-Expands-RampD-Facility-in-China/ArticlesStandard/Article/detail/790082?contextCategoryId=35097 http://www.pharmtech.com/pharmtech/Online+Only/Eli-Lilly-Receives-FDAWarning-Letter/ArticleStandard/Article/detail/788019?contextCategoryId=35097 http://www.pharmtech.com/pharmtech/News/EMA-Streamlines-Working-Parties/ArticleStandard/Article/detail/790081?contextCategoryId=35097

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - October 2012

Pharmaceutical Technology Europe - October 2012
Contents
Cover Story: CROs and CMOs Have Cause to celebrate Annual survey shows growth for outsourcing providers
Quality by Design: A Contract Organisation’s Perspective on Overcoming Obstacles to Implementing QbD
News Bites and Trends on Twitter
Outsourcing Pharmaceutical Infrastructure Operations
EMA Focuses on Greater International Collaboration
Producing Cocrystals
Blogs: Sanofi job cuts; confidential data risk; Alzheimer’s research; and patent cliff.

Pharmaceutical Technology Europe - October 2012