Clinical Research experts from across Central Eastern Europe, CIS countries and Turkey gathered in Vienna on February 13th and 14th on occasion of Jacob Fleming’s Conference on Optimizing Clinical Trials in CEE & CIS Region. The former Austro-Hungarian capital was a an ideal host city for representatives from leading pharmaceutical companies as well as national medicinal authorities to exchange their knowledge and viewpoints on best practices and new trends for optimizing the conduct of clinical trials in the region. The proactive delegates engaged in interesting discussions in interactive sessions that provided true learning experiences. Also the many networking opportunities over cocktail receptions and dinners contributed to the very stimulating conference atmosphere.
Day 1, moderated by an excellent chairman Heinrich Klech of Eli Lilly, started off with a keynote presentation by Károly Fäller, Clinical Research Director for Bulgaria, Romania and Russia at AstraZeneca Hungary. He successfully set the scene for the day by giving a good overview of the current environment for conducting clinical trials in CEE-CIS. Katarzyna Czabańska of Pfizer Poland then provided a detailed insight on the legislative environment – including the state of the EU Directives’ implementation – for conducting clinical trials in Poland. The following presentation by Sule Mene, Board Member of the Clinical Research Association Turkey and Head of Clinical Research of Lundbeck Turkey specified the challenges and opportunities of clinical trials in this high-potential country. The last presentation before lunch looked at the specifics of conducting Clinical Trials in the three Baltic States – Nilss Poritis of the Baltic-based company JSC Grindeks illuminated the challenges and opportunities as well as processes regarding Clinical Studies in each of the markets. The final panel discussion gave the opportunity to ask specific questions to the speakers and to wrap up the morning session by addressing the public opinion of Clinical Trials in the Region.
The afternoon session started off with an eye-opening speech on Non-interventional Clinical Studies by Martin Možina, Chairman of the Slovenian National Committee for Clinical Trials. Referring to Alexander the Great’s Empire Chairman Heinrich Klech then provided his expertise with a truly relevant presentation on the pros and cons of Multiregional Clinical Trials and what they could offer to the CEE-CIS Region. The session after coffee saw a very lively panel discussion on the regulative and legislative environment for Clinical Trials in the Region. The expert panelists Prof. Tamas Paal (Hungarian National Institute of Pharmacy), Siniša Tomič (Croatian Agency for Medicinal Products & Medical Devices), Martin Možina (Slovenia) and Elzbieta Golab (Poland) answered proficiently the challenging questions from the audience regarding the opportunities and shortcomings of the transposition of the EU Directive. The day closed with an interactive workshop co-moderated by Christa Janko and Sherry Wilkinson-Armstrong from the Vienna School of Clinical Research. The two ladies engaged the participants in working group discussions on specific issues of Capacity Management in Clinical Research of which the constructive outcomes were thereafter presented to the full plenary.
At the cocktail networking event and over dinner at a close-by restaurant the speakers and delegates re-captured the day in a casual atmosphere accompanied by delicious food. Lively discussions continued even after the official programme’s end until late hours.
The second conference day started off with a keynote presentation by the Chair Roy Gomez, Director of Clinical Research CEE Region of Pfizer, who presented the strategies for effective outsourcing in the region. Bristol-Myers Squibb’s Guy Bafort, Director for Regional Clinical Operations in CEET then provided practical insights on the lessons learned from In-House vs. outsourced Clinical Trials in diverse countries of the region. Bogdan Nietubyc, representing Averion (former Hesperion) in Poland, gave an appreciated CRO-viewpoint on improving clinical outsourcing by presenting a case study on their rescue project in CEE/CIS countries. Pieter Guelen of the Dutch CRO Association ACRON and co-founder of the European CRO Federation EUCROF then provided his expertise on how to audit a CRO based on recently published draft guidelines by European authorities. At the close of the morning session Alexander Alfimov of Novartis Russia delivered a highly relevant speech on effective patient recruitment in Russia by providing case studies insights on the most appropriate strategies and tools as well as how to build beneficial relations with investigators and hospitals. After lunch the speakers were engaged in an interactive panel discussion with the audience on ways of optimization Patient Recruitment & Retention as well as the question whether the emerging markets of China and India are real competitors for the region given their cost-effectiveness and tremendous patient numbers. The last conference block looked at effective CRO selection and performance measurements. Edibe Taylan, Medical and Public Affairs Director of Sanofi-Aventis Turkey, gave highly appreciated insights on how to select a CRO and to establish a long-term partnership with CROs in Turkey. Finally, Victoria Kosmacheva of GlaxoSmithKline Russia was fully matching the expectations of the audience as she illustrated how CROs and Sites can be best selected in her country and how to cooperate effectively.
The feedback we received from the participants was excellent and so we hope that everybody returned home with a lot of useful ideas on how to optimize their clinical trials in their home office and country. This was certainly the aim of the conference!
Given the great success of this event we look into how a follow-up conference on yet further optimizing the conduct of Clinical Trials in this promising and exciting Region could look like. If you would like to contribute or participate do not hesitate to contact us - and certainly do not miss the opportunity to join us there!
Samuel Leiser
International Project Leader
Jacob Fleming Group
