“Breakfast with a Logistician” is a novel professional platform where industry experts can discuss noteworthy issues in the field of clinical research logistics as it pertains to Russia, former CIS countries and the countries of Eastern Europe.
The breakfast format allows the guests to communicate in a relaxed and friendly atmosphere and share news and opinions with pharmaceutical business experts and clinical research logistics specialists.
The first event took place in the spring of 2018 and was met with a momentous enthusiasm. “Breakfast with a Logistician” turned out to be very well received, and now we are striving to make the follow-on meetings even more thought-provoking and productive. To this end we chose a very difficult topic for discussion and invited new exciting speakers.
The theme of the upcoming event is “The risks associated with thermolabile shipments in clinical research logistics”.
Transportation of temperature-sensitive or thermolabile cargo is not an easy task and can be fraught with a lot of nuances and risks that logisticians need to be aware of. First and foremost, these are the risks that arise during both storage and transportation of thermolabile materials. How do we identify and reduce such risks, most importantly, whether there exist prêt-à-porter risk management solutions in the logistics of clinical research? Our invited industry experts will answer these and other questions during the business breakfast.
Please meet the distinguished speakers of upcoming event:
Dmitry Goryachev. Director of the Center for Evaluation and Control of Medicinal Products, FSBI “SCEEMP” of the Ministry of Health of Russia Igor Stefanov. General Manager, Synergy Research Group Vitaly Shakhnazarov. Quality Director, COREX Dmitry Shishkin. Department Head. Liability Insurance Management. Ingosstrakh
Together with our speakers, you are invited to address the aforementioned topics from the viewpoint of:
1. Pharma. What risks are faced by manufacturers and CROs when they employ logistics operators to transport and store study drugs and clinical trial materials?
2. Regulatory authority. The focus is on the legal framework.
3. Logistics partners. The algorithms of identifying project risks and its mitigation will be presented.
The invited experts will complete the series of presentations and summarize the results by formulating potential risk management solutions for the pharmaceutical industry.
The event will be moderated by Maria Zaitseva, MD, PhD, a well-recognized expert in the field of regulatory affairs, Head of Quality Assurance Department at the Federal State Budgetary Biological Agency of Russia, National Industry GLP Inspector.
If you would like to attend this thought-provoking event, please RSVP by sending an email to: firstname.lastname@example.org
The pharmaceutical industry has faced numerous challenges since the beginning of 2021 including the rush to supply COVID-19 vaccines. The start of the year also saw the departure of the UK from the EU and theEuropean Medicines Agency (EMA). The Medicines and Healthcare Products Regulatory Agency (MHRA) is now fully in charge of all regulatory matters, oversight of clinical research and approval of medicines.
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