Vladislav Shestakov, Director of the State Institute of Drugs and Good Practices started the day with highlighting main discussion topics such as: distinctions of pharmaceutical legislation and GMP regulation in different countries, regulatory convergence of GMP inspections and procedures, impact of global regulatory approaches on development of drugs and opportunities for country-to-country interaction.

An important goal of the event is to harmonize the GMP rules and make efforts for mutual recognition in the international community. This year more than ten foreign regulators are taking part in the conference, including Japan, the U.S., Cuba, Mexico, Bulgaria, Croatia, Kazakhstan, Kyrgyzstan and others.

«GMP harmonization and mutual recognition – as we know – are quite a job to do. In this regard, today the ability to integrate effectively into crosscountry associations is at the forefront. Day Two of the conference will be mostly covering the said issues,» announces Vladislav Shestakov.

Akrihin JSC organized an expert discussion of the issues of smart use of resources and country-to country cooperation in GMP area as well as mutual recognition. Elena Popova, Director for Regulatory Policy in Healthcare Sector, Association of International Pharmaceutical Manufacturers (AIPM) moderated the session.

Within the framework of the session, the participants discussed the role of the European Medical Agency in GMP inspection and quality assurance; current issues of drug quality evaluation throughout its life cycle; reviewed Russian and international requirements; specifics of pharmaceutical legislation and GMP regulation in different countries; approaches to GMP inspections in different regulatory jurisdictions (the EU vs the U.S.), etc.

For example, Isabela Majich – Head of the Croatian Inspectorate (HALMED) – talked about practical outcomes of the MRA of GMP inspections signed between the United States and the European Union. She noted that «capability» of the Inspectorate does not mean adhering to the inspection order and production control identical to those of the US FDA. She cited some assessment criteria of inspectorate’s preparedness (each of those would suffice): legal and regulatory power to conduct inspections in accordance with the GMP rules, experience of ethical resolution of conflicts of interest, experience of evaluation and mitigation of risks, employment of inspectors with relevant qualifications, work experience, skills and knowledge necessary to identify manufacturing malfunctions that pose potential risks to patients, and tools available for protection of public from harm of low-quality pharmaceuticals.

Stephan RÖNNINGER – AMGEN’s Director for Quality and External Relations – drew attention to the existing state of affairs in GMP inspections. There have been a lot of changes and improvements: innovation and best practices have drowned out the traditional industries, the volume of foreign inspections increased significantly compared to 2010, new laws and regulations came came into force. There is almost no interruption in pharmaceuticals supplies.

Bogdan Kirilov – Executive Director of the Bulgarian Drug Agency – noted that successes of the Russian GMP Inspectorate and the Russian pharmaceutical industry would have been impossible without their cooperation based on two principles – professional devotion and genuine interest.

At the end of the session, Anna Arutyunova – Quality Director of Valenta Pharm – presented on the company’s tactics for compliance with quality standards, «Quality policy exists in our company since its foundation. Because it is aimed at the company’s strategic goals, we have been carrying out production activities for many years in accordance with GMP standards. One of the fundamentals of our company’s quality policy is ongoing improvement, therefore, we extended the standards of good practices to cover not only the manufacture, but also many other aspects: i.e. preclinical and clinical GLP/GCP trials, pharmaceutical QbD developments, QPPV pharmacovigilance, etc. One of the tactical moves in the process of improvement was the launch of a high-tech research and production complex, where all processes are implemented in accordance with the best world quality standards. This means to demonstrate efforts Valenta Pharm takes to follow international standards and apply the best world’s practices throughout the life cycle of innovative and other drugs – from their development, research and registration to production and subsequent monitoring. We readily embrace advanced technologies, digitalization of technological processes, and the newest standards personnel development, procedures, and infrastructure. I can say with confidence that quality assurance should be a strategic goal of all responsible manufacturers who value their reputation, aim at development and seek to improve life quality of their fellow citizens.»

Tatarstan’s pharmaceutical industry attracts investments into the region – that was the motto for presentation of the Republic’s investment, scientific, and educational capacity for pharmaceutical and biopharmaceutical companies that plan to localize in Russia, organize contract manufacturing or joint development of innovative drugs.

«Significance of the conference for each of us and for pharmaceutical industry in general is obvious. It is necessary for knowledge transfer, sharing information on the GMP main trends in the pharmaceutical market. Compliance with GMP standards is an important development strategy for Russian pharmaceutical industry. New markets and increases exports of domestic products will remain out of reach without strict compliance with international quality standards. The conference this year substantially expanded its business agenda, there appeared more opportunities for discussions and negotiations between experts and pharmaceutical market professionals. The conference revealed Tatarstan’s capacity. The Republic has created a unique investment climate. Scientific and technical potential for the successful development of the pharmaceutical industry, universities, high tech laboratories – all are concentrated here», – commented Timur Khanannov, CEO of TatKhimPharmPreparaty JSC.

International experience in implementation of labelling of medicines for human use was also part of the international day discussions. Experts exchanged opinions on mandatory labeling in Russia, reviewed international regulators’ take on introduction of pharmaceuticals traceability systems, and the current state of affairs in Russia.

Joseph Traple – Head of the Global Technologies Division of Takeda Pharmaceuticals International – spoke about international experience in implementing labeling and came to the following conclusion, «It is necessary to demand that suppliers stick to standardized solutions using software that complies with the GAMP5 standard, as well as GMP regulatory requirements.»

Andrey Akhantyev – Head of Economic Security, GEROPHARM – noted that his company supports pharmaceutical labeling in all seriousness, «We fully support the project introducing labeling and monitoring of drugs circulation, because we believe that this will completely clear the pharmaceutical market of adulterated and falsified products. We have equipped our production lines with the necessary equipment and software, and we have repeatedly tested the entire supply chain., At the present time – however – it is extremely important to agree on clear, transparent, and consistent rules – especially for those participants who are yet to join the project.

A majority of pharmaceutical manufacturers fear that uncalled for and unjustified cryptographic protection (with codes generated and sold by a monopolistic private company) as well as absence of clear regulations will slow down the project and fail Federal law 61 introducing mandatory labeling. It may also increase risks associated with rejected products, exports of drugs, dependence on an outsourced crypto code, transfer of a hefty array of commercial data to a private company with vague obligations, and grave liabilities to stakeholders in pharmaceutical industry and the government.»

Overview of GEP trends. EAEU ISPE discussion rounded up the international agenda. The discussed issues included technical regulation and standardization of manufacturing guidelines and rules, interaction between professionals in the pharmaceutical industry, high tech API production, and Pharma 4.0.

After the panel discussion, Vladislav Shestakov, Director of the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade – lead the closing ceremony of the III All-Russia GMP Conference. Participants voted online to identify the most important trends in the industry that would appear in the conference resolution. German Inozemtsev, Chief Editor of the publishing house Pharmaceutical

Vestnik noted that very few professional conventions could boast of increased number of delegates and at the same time maintain high organization standards. At the end of the day, the participants chose the city for the 2019 conference. The final event was organized in partnership with Amgen.

Please be reminded that on August 29 – Day Three of the conference – will be filled in with GxP practical master classes offered by leading experts in current issues encountered by pharmaceutical manufacturers: e.g. GMP inspections, data integrity, qualified persons, production regulation (a case study of radiopharmaceuticals).

Partners of the III All-Russia GMP Conference:
General partner – Valenta Pharm; strategic partners: Gedeon Richter, TatKhimPharmPreparaty JSC; partners of the conference: Astellas Pharma, Takeda Pharmaceuticals, TEVA; partners of the sessions: Akrihin, Amgen, Bosnalijek, PRO.MED.CS Prague a.s., Pharmimeks, Sanofi Russia; special partners: GEROPHARM, NatsImBio.

The conference has been organized by the Russian Ministry of Industry and Trade together with the State Institute of Drugs and Good Practices, the conference is operated by «S-Group» Center for Corporate Communications.