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29.06.2017 - A DIALOGUE BETWEEN REGULATORS AND THE PHARMA INDUSTRY ON MODERN GMP INSPECTION STANDARDS

On June 27, 2017 the Association of International Pharmaceutical Manufacturers (AIPM) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), supported by the State Institute of Medicines and Good Practices of the Russian Ministry of Industry and Trade (SIM & GxP), held a scientific and practical Workshop Modern tendencies in GMP inspections of pharmaceutical manufacturers. Representatives of regulatory authorities and expert organizations from Russia and Kazakhstan, representatives of headquarters and Russian branches of international pharmaceutical companies as well as recognized international experts participated in this discussion.

The speakers were: Vladislav Shestakov, Director, SIM & GxP, Elena Denisova, Deputy Director, Department of Pharmaceutical and Health Industry Development, Ministry of Industry and Trade of the RF, Natalia Chadova, Head of Department of Inspections of Pharmaceutical Manufacturing Plants, SIM & GxP, Elena Popova, Senior Director, Regulatory Affairs and Healthcare Policy, AIPM, Dr.- Ing. Stephan Rönninger, Adjunct Assistant Professor, the George Washington University, USA, Lina Ertle, representing EFPIA, former lead GMP inspector and Head of Quality Assessment Unit, NSM, France, Helga Peters, GMP-expert in compliance and quality management, certified IRCA auditor, F.Hoffmann-La Roche, Milkhail Khazanchuk, Head of Investment Policy and Supply Chain Committee, AIPM, representatives of the Russian Scientific Center for Human Medicinal Products Assessment of the Ministry of Healthcare of the RF and other experts.

Opening the Workshop discussion, on behalf of the organizers and being a moderator, Elena Popova said that the goal of this meeting was to discuss modern trends in GMP inspections, current inspection practices and procedures, most common issues arising in the course of inspections, sharing experience and strengthening mutual trust between regulators and systems in different countries on the one hand and the pharma industry on the other hand, as well as opportunities of using risk-oriented approaches in inspecting pharmaceutical manufactures and prospects of integration of the national regulatory system into the global regulatory context. “Manufacturing is the key element of the life cycle of a medicinal product, but it is closely related to the other stages of medicinal products circulation such as development, obtaining marketing authorization and post-marketing circulation, all these stages being regulated by different competent authorities. And today’s Round Table is not just a dialogue between the pharma industry and regulatory authorities, but also, which is equally important, a dialogue between regulatory authorities and expert organizations”, Elena Popova underscored.

Supporting the focus on compliance with the current GMP requirements and acknowledging the important organizational efforts to achieve it, the Workshop participants expressed their hope that to ensure maximum procedural efficiency and rational use of the existent infrastructure in the context of current legal, administrative and workforce constraints, Russia would adopt modern risk-oriented approaches to GMP inspections. It was also underlined that it was important to ensure prompt harmonization of the national regulatory system with the modern international practices and bring the national inspections practice in line with the latest standards of the Eurasian Economic Union.

In his speech Vladislav Shestakov drew the audience’s attention to the fact that determination of SIM & GxP to have a productive dialogue with the pharma industry would help in finding constructive solutions to all issues arising in this process. When possibilities of harmonization of regulatory requirements were being discussed, it was suggested that Inspection Trust Index be developed to enable a comprehensive assessment of an inspection from the procedural point of view and also in terms of the existing training programs. ‘We are interested in seeing our pharma industry being in line with the international trend,” Vladislav Shestakov said.

The Workshop participants also welcomed the fact that Russian regulatory authorities were open for dialogue and ready to join the discussion at international level jointly with other inspectorates. “It is of the utmost importance that this dialogue and sharing views among representatives of various inspectorates continue in future. It will help this relationship achieve a new, higher level of trust which means mutual recognition of inspection results. Both regulators and pharmaceutical manufacturers face the same growing challenges. Now, with rapidly advancing technologies, manufacturing processes and standards are constantly being updated, innovative pharma companies manufacture novel medicinal products using the latest technologies and more advanced testing methods, and this means that regulators should also keep pace with the latest trends and changes,” summarized the participants of the Workshop.

«Thanks to the joint effort of all the stakeholders we managed to organize this event on the highest professional level and share constructive opinions on how to further improve regulatory activities and enforcement practices in the context of organizing and implementing GMP inspections. We are sure that such a direct dialogue of regulatory authorities, expert organizations and the pharma industry will continue in the same constructive format,” Elena Popova said, closing the Workshop discussion.

 

Information on key participants:

 

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The State Institute of Medicines and Good Practices of the Russian Ministry of Industry and Trade (SIM & GxP) is an expert agency authorized to conduct GMP inspections of manufacturers of human medicinal products being produced outside the Russian Federation, for the purpose of issuing an certificate on pharmaceutical manufacturer’s compliance with GMP requirements.

 

Association of International Pharmaceutical Manufacturers (AIPM) brings together 60 international companies, which account for over 80% of world pharmaceutical production and more than 60% of the volume of medicines supplied to the Russian Federation.

 

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the EU pharma industry. EFPIA consists of more than 30 national associations and 40 leading pharma companies. Thus, the Association represents the interests of over 1,900 companies in the EU specializing in research and development as well as in market launch of modern medicinal products, making a major contribution to improving patients’ health and quality of life worldwide.

 

For additional information, please contact:

Irina Sheykkha, Legal and Communications Director, AIPM

Tel.: +7 (495) 933 70 40, e-mail: I.Sheykkha@aipm.org




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