Pharmaceutical Executive Europe - May 2008 - (Page 8) 8 News & Analysis May 2008 Pharmaceutical Executive Europe NICE responded to the judgement by explaining that it will review its findings but was at pains to remind people that the ruling does not necessarily mean that the drugs will become available. Furthermore, Andre Dillon, chief executive of NICE, said that the ruling could result in making the approval process slower and more complicated. Europe and India shake hands on safety European and Indian healthcare organisations have joined forces to improve the quality and safety of medicines. The European Directorate for the Quality of Medicines and HealthCare (EDQM) has announced that is has reinforced its relationship with the Ministry of Health of India and the Indian Pharmacopoeia Commission (IPC). The EDQM and Indian authorities have worked closely together since 2002, but they have now identified several potential areas of collaboration including elaboration of chemical and herbals monographs; development of joint inspections of manufacturing sites under the framework of the European Pharmacopoeia procedure of certification; promotion of common training activities in the pharmacopoeial field; scientific cooperation by inviting pharmaceutical scientists to the EDQM; facilitation of information exchange; and observer status for the European Pharmacopoeia to the Indian Pharmacopoeia Commission. Drugs Controller General of India, Dr Surinder Singh, has said that he looks forward to working with the European agency. “We can exchange our scientific expertise and work together on a variety of activities that will benefit all consumers of medicines in our respective countries.” www.edqm.eu ON THE MOVE Dr Dimitri Goundis has been appointed project director of clinical development at Anavex Life Sciences Corp (Switzerland). Dr Goundis will establish a clinical development team as well as select and manage the contract research organisations that will work with ANAVEX to move its drug candidates through clinical trials in preparation for submission to the FDA and other regulatory agencies. Dr Goundis has more than 20 years’ experience in the management of clinical trials, including leadership positions at Speedel AG, The Medicines Company and Roche. Anavex plans to enter human clinical trials with its lead Alzheimer’s compound within the next 12 months. John Rogers has been appointed director, process solutions, for Octagon Research Solutions Inc (US). Mr Rogers will be responsible for leading Octagon’s Process Consulting team, supporting the development, execution and delivery of premiere consulting services across global engagements. Prior to joining Octagon, Mr Rogers served as director, Regulatory Services as well as director, Enterprise and Strategic Operations Solutions at Stelex. Trisha Dowling has joined Biomatrica (US) as vice president of sales and marketing. Prior to joining Biomatrica, Ms Dowling served in the same role at Continental Lab Products, a division of Pelican Life Sciences where she was responsible for direct sales, global marketing, product commercialisation and business development. Biomatrica’s interim vice president of sales and marketing, Jim Johnson will continue to serve as an advisor on the Business Advisory Board. MacroGenics Inc (US), a private biotechnology company focused on the development of products to treat autoimmune disorders, cancers, and infectious diseases, has announced the appointments of Dr Jean-Christophe Tellier as executive vice president and chief commercial officer and Mr James Karrels as vice president and chief financial officer. Dr Tellier joins MacroGenics after 20 years in commercial development at Novartis. Mr James Karrels has been at Jazz Pharmaceuticals, Inc. since 2005, most recently serving as executive director of finance. Nancy Motola, PhD, has joined Rib-X Pharmaceuticals, Inc (US) as senior vice president of regulatory affairs. Dr Motola brings to Rib-X more than 20 years of years of experience in regulatory affairs and quality, 25 years total in the pharmaceutical and biotechnology industry and has been Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professionals Society (RAPS) since 2002. Most recently, Dr Motola held the positions of vice- and senior vice president, Regulatory Affairs and Quality at Alexion Pharmaceuticals Inc. WIN WITH DHL HEALTHCARE. Take part in our latest online survey today for your chance to win a stylish iPod Nano! Just visit: Sponsored by: www.dhl-healthcare.com http://www.edqm.eu http://www.dhl-healthcare.com http://www.dhl-healthcare.com
Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Europe - May 2008 Pharmaceutical Executive Europe - May 2008 Contents From the Editor News and Analysis Calendar Rising in the East Use Your Strategic Discretion A Blueprint for Success Market Access and the Patient Activating Effective Product Differentiation What Doctors Want IC Success in Four Steps Pharmaceutical Executive Europe - May 2008 Pharmaceutical Executive Europe - May 2008 - (Page Bellyband1) Pharmaceutical Executive Europe - May 2008 - (Page Bellyband2) Pharmaceutical Executive Europe - May 2008 - Pharmaceutical Executive Europe - May 2008 (Page Cover1) Pharmaceutical Executive Europe - May 2008 - Pharmaceutical Executive Europe - May 2008 (Page Cover2) Pharmaceutical Executive Europe - May 2008 - Contents (Page 3) Pharmaceutical Executive Europe - May 2008 - From the Editor (Page 4) Pharmaceutical Executive Europe - May 2008 - From the Editor (Page 5) Pharmaceutical Executive Europe - May 2008 - News and Analysis (Page 6) Pharmaceutical Executive Europe - May 2008 - News and Analysis (Page 7) Pharmaceutical Executive Europe - May 2008 - Calendar (Page 8) Pharmaceutical Executive Europe - May 2008 - Calendar (Page 9) Pharmaceutical Executive Europe - May 2008 - Calendar (Page 10) Pharmaceutical Executive Europe - May 2008 - Calendar (Page 11) Pharmaceutical Executive Europe - May 2008 - Rising in the East (Page 12) Pharmaceutical Executive Europe - May 2008 - Rising in the East (Page 13) Pharmaceutical Executive Europe - May 2008 - Use Your Strategic Discretion (Page 14) Pharmaceutical Executive Europe - May 2008 - Use Your Strategic Discretion (Page 15) Pharmaceutical Executive Europe - May 2008 - A Blueprint for Success (Page 16) Pharmaceutical Executive Europe - May 2008 - A Blueprint for Success (Page 17) Pharmaceutical Executive Europe - May 2008 - Market Access and the Patient (Page 18) Pharmaceutical Executive Europe - May 2008 - Market Access and the Patient (Page 19) Pharmaceutical Executive Europe - May 2008 - Market Access and the Patient (Page 20) Pharmaceutical Executive Europe - May 2008 - Market Access and the Patient (Page 21) Pharmaceutical Executive Europe - May 2008 - Activating Effective Product Differentiation (Page 22) Pharmaceutical Executive Europe - May 2008 - Activating Effective Product Differentiation (Page 23) Pharmaceutical Executive Europe - May 2008 - Activating Effective Product Differentiation (Page 24) Pharmaceutical Executive Europe - May 2008 - What Doctors Want (Page 25) Pharmaceutical Executive Europe - May 2008 - What Doctors Want (Page 26) Pharmaceutical Executive Europe - May 2008 - What Doctors Want (Page 27) Pharmaceutical Executive Europe - May 2008 - IC Success in Four Steps (Page 28) Pharmaceutical Executive Europe - May 2008 - IC Success in Four Steps (Page 29) Pharmaceutical Executive Europe - May 2008 - IC Success in Four Steps (Page 30)
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.