As part of the conference "Dialogues on Clinical Research," a section on "Regulatory Changes in Clinical Research: GCP and Regulatory Practice" was held, dedicated to current changes in the regulation of clinical research and their impact on companies' practical activities. The session was successful and generated lively interest from the professional community.
During the meeting, participants discussed: the first results of applying the new EAEU GCP requirements, their alignment with international ICH GCP standards, as well as issues of implementing regulatory approaches and preparing documentation.
Natalia Rudinskaya, Director of Key Clients at the translation company JANUS Worldwide, highlighted in her report the complexities of translating medical documents taking into account the regulatory requirements of different countries, effective process automation tools, ways to optimize costs and reduce task completion times without losing quality.
Dmitry Burgaev, Head of the Regulatory Department at X7 Research, presented a report "EEC Decision No. 63: First Results and Practice of Applying the New Edition of EAEU GCP." The expert shared practical experience in implementing the updated requirements, typical difficulties faced by companies, and provided recommendations for adapting workflows to the new norms.
Yulia Dutikova, Head of Patenting Group in Medicine and Pharmaceuticals, Candidate of Biological Sciences (Oncology), Russian Patent Attorney, Eurasian Patent Attorney at the Patent and Law Firm "A. Zalesov & Partners," examined in her report: key criteria for assessing patentability taking into account clinical research data; nuances of working with documentation for filing patent applications; current legal aspects in the field of patenting pharmaceutical developments; and practical examples from professional practice.
The discussion was rich and constructive: participants actively asked questions, shared their own experiences, and proposed ideas for the further development of the industry.
We thank all participants and speakers for their contribution to the productive discussion!
During the meeting, participants discussed: the first results of applying the new EAEU GCP requirements, their alignment with international ICH GCP standards, as well as issues of implementing regulatory approaches and preparing documentation.
Natalia Rudinskaya, Director of Key Clients at the translation company JANUS Worldwide, highlighted in her report the complexities of translating medical documents taking into account the regulatory requirements of different countries, effective process automation tools, ways to optimize costs and reduce task completion times without losing quality.
Dmitry Burgaev, Head of the Regulatory Department at X7 Research, presented a report "EEC Decision No. 63: First Results and Practice of Applying the New Edition of EAEU GCP." The expert shared practical experience in implementing the updated requirements, typical difficulties faced by companies, and provided recommendations for adapting workflows to the new norms.
Yulia Dutikova, Head of Patenting Group in Medicine and Pharmaceuticals, Candidate of Biological Sciences (Oncology), Russian Patent Attorney, Eurasian Patent Attorney at the Patent and Law Firm "A. Zalesov & Partners," examined in her report: key criteria for assessing patentability taking into account clinical research data; nuances of working with documentation for filing patent applications; current legal aspects in the field of patenting pharmaceutical developments; and practical examples from professional practice.
The discussion was rich and constructive: participants actively asked questions, shared their own experiences, and proposed ideas for the further development of the industry.
We thank all participants and speakers for their contribution to the productive discussion!