Pharmaceutical Executive Europe - May 2008 - (Page 13) Pharmaceutical Executive Europe May 2008 European Union 13 and 24/2002. The main improvements provided by these two decrees were the implementation of a timeframe for the authorisation process and the establishment of a two-tier system of Central and Local Ethics Committees for ethical approval. In addition, the Decrees regulate safety reporting, reinforce ICHGCP/GMP rules and specify the professional experience required by staff participating in clinical trials. These Decrees have since been partly superseded by Ministerial Decree 35/2005, introduced in September 2005, which modified the role of the local ethics committees in the approval process. In October 2005, a new Drug Act, which regulates issues such as liability insurance and evaluation/approval timelines, was introduced. Due to differing interpretations of the various Decrees by the National Institute of Pharmacy local Ethics Committees, institutions and sponsor companies, there were some initial inconsistencies in the implementation of the legislation. For example, some local Ethics Committees were reluctant to relinquish their role in the approvals process. However, following a co-operative effort between all the parties concerned, these issues were clarified and the legislation has been implemented as standard practice. The successful implementation of legislation has gradually paved the way for improvements in the approval and conduct of clinical trials. Until the year 2000, the number of clinical trials conducted annually grew rapidly. Since then, growth has slowed to an average of approximately 300 approvals per year, with an approximate enrolment of 15000 subjects. Early implementation of EU Directives, with predictable approval timelines, together with the clinical trial expertise and patient population available in the country make Hungary an attractive centre for conducting clinical trials. documents are required, the process is less time consuming. Since implementation of the EU Directives, clinical trials are now registered in the EMEA database and adverse-event reporting is performed online, thus ensuring that patient safety issues are reported in a timely manner. Conclusion Over the last 10 years, the number of clinical trials conducted in CEE has increased significantly. Historically, countries in CEE were associated with less transparent and prolonged submission, approval and drug importation procedures. …since their accession to the EU, many CEE countries’ incorporation of EU Directives into national legislation, startup timelines, regulatory requirements and data quality are now equivalent to those in western Europe and the USA. Latvia In Latvia, the EU Directives have been incorporated in Cabinet Regulation No. 17 of 15 January 2008, which has been in force since 1 March 2008. This legislation covers the procedures for the conduct of clinical trials, in accordance with GCP for labelling , investigational products and for verifying compliance with GCP . Since accession to the EU and the adoption the relevant EU Directives, the process of approving and conducting clinical trials in Latvia has been brought into line with the rest of Europe. The list of documents required for submission and approval by the State Agency of Medicines and Ethics Committees is now similar to that in other EU countries, although additional requirements include documentation covering Sponsor and Investigator civil liability and terms and conditions of insurance. The EU Directive has been successfully incorporated into national legislation and has received a positive response from the pharmaceutical industry and the medical profession. For CROs, implementation has improved and streamlined the submission and approval process. In particular, the documentation required from the sponsor has been clarified and, because fewer country-specific However, since their accession to the EU, many CEE countries’ incorporation of EU Directives into national legislation, start-up timelines, regulatory requirements and data quality are equivalent to those in western Europe and the USA. Thus, harmonisation has helped to make CEE a primary focus for the pharmaceutical and CRO industries for conducting clinical trials. About the Author Dr Ina Ruehl-Bagheri has more than 17 years clinical research industry experience, and has expertise in a variety of therapeutic areas (including pulmonology, oncology, cardiovascular). In 2006 Dr Ruehl-Bagheri joined ICON Germany as vice president, clinical operations Europe with responsibility for business in Germany, Poland, Italy and Israel. This article also features contributions from the following ICON personnel: Andrea Ajtay, Senior clinical research associate and Istvan Somogyi, CRA manager (Hungary); Monika Stepniewska, director clinical operations (Poland); and Svetlana Riekstina, director, clinical operations (Latvia).
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)
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