The ECA conducted a workshop on “Regulatory Requirements for the Registration of Medicinal Products and Post-Registration Liabilities in the Countries of the European Union. Regulations on Biosimilars.” for the representatives of the State Expert Center of the Ministry of Health of Ukraine. The staff of the center is in charge of registration of medicinal products in Ukraine. This workshop was supported by Sanofi-Aventis Ukraine LLC.
With regard to the workshop Sanofi-Aventis issued the following press release:
"Kyiv, July 14, 2011 – With the support from Sanofi-Aventis Ukraine LLC, one of the leading pharmaceutical companies on the Ukrainian market, a workshop was held by the European Compliance Academy dedicated to the topic of “Regulatory Requirements for the Registration of Medicinal Products and Post-Registration Liabilities in the Countries of the European Union. Regulations on Biosimilars.” The workshop was held for the representatives of the State Expert Center of the Ministry of Health of Ukraine, in charge of registration of medicinal products in Ukraine. Purpose of the workshop was to provide information about European practice of registration of medicines, and about regulation of pharmaceutical market of the EU in general, as well as to facilitate harmonization of European and Ukrainian regulatory requirements to quality of medicinal products.
Sanofi-Aventis Ukraine, being a part of the global pharmaceutical sanofi group, carries out its business activities in Ukraine in strict compliance with the standards of EU, and it also makes a significant contribution to development of Ukrainian healthcare system in general by cooperating with healthcare authorities, scientists, representatives of medical community and patients. Particularly, the company supports initiatives that enable Ukrainian professionals to learn about the best European practice as to registration and quality control of medicinal products.
The main speaker on the workshop, representative of the European Compliance Academy, Dr. Joseph Hofer, gave detailed information about European pre-registration expertise of medicines, the ways of interacting with competent regulatory authorities in the EU countries, and about the functions of European regulatory authorities. The workshop’s discussions focused on comparative analysis of Ukrainian and European procedures of medicine and healthcare product registration, and on the steps that Ukraine should make to successfully integrate into the European regulatory framework as to this sphere.
Jean-Paul Scheuer, General Manager of Sanofi-Aventis Ukraine LLC: "Sanofi is committed to caring for people, and their health is of the highest value to us. We cooperate closely with the government authorities, scientific institutes and medical community, and we support various initiatives that contribute to the healthcare system development in Ukraine.
Today’s high-level workshop became yet another proof of our approach and long-term commitments to Ukrainian patients and professionals.
We endeavor to make quality and innovative medicines available for Ukrainian people, just like the patients from other European countries, and timely registration of drugs in compliance with the European standards plays a key part in this: It provides people with access to proper medical treatment and improves the quality of their lives.”
Dr. Joseph Hofer, European Compliance Academy (ECA): "I am happy to visit Ukraine and take part in the workshop intended to bring together the representatives of Ukrainian authorities and pharmaceutical community for productive cooperation as regard to the topic of registration and quality control of medicines. There is no doubt that effective advancement of Ukrainian pharmaceutical industry is possible only if European experience and standards are taken into concideration. I am sure that after this workshop, Ukraine came one step closer to its integration into the European community.”
Iryna Kudriavtseva, Deputy General Director of the State Expertise Center of the Ministry of Health of Ukraine, Director of Department for Registration (Re-Registration) of Medicinal Products and Making Changes to Registration Dossiers: “Thanks to such initiatives that reveal the many years’ global experience in pharmaceutical industry, we are able to learn more about current European requirements to the quality of medicinal products, activities of pharmaceutical companies, and medicinal product registration process. The workshop became another important step for us on the road to improving regulation of pharmaceutical industry in Ukraine in compliance with European standards.”
About Sanofi-Aventis Ukraine
Sanofi-Aventis Ukraine LLC is part of Sanofi, global and diversified healthcare leader working on researching, developing and providing therapeutic solutions addressing the patients’ needs. In the field of healthcare, Sanofi specializes on seven growth platforms: solutions for diabetes, human vaccines, innovative products, rare diseases, consumer healthcare, developing markets, and animal health.
About European Compliance Academy (ECA)
The European Compliance Academy (ECA) was founded in 1999 as an independent educational association and is working on the issues of pharmaceutical quality assurance and Good Manufacturing Practice (GMP) compliance. The Academy has close to 4,000 members representing more than 60 countries. The purpose of ECA is the exchange of information between representatives of the industry, state authorities that regulate manufacturing and circulation of medicines, and the scientific institutes. The ECA holds its activities in cooperation with ConceptHeidelberg, a company involved in organization of professional conferences.