Clinical medical product studies workshop held in Penza
Penza, 26 March 2015. PenzaNews. An educational workshop on clinical study procedure for medical products, organized by the Center of Cluster Development, was held at the Penza technopark “Rameev” on Thusday, March 26.
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The event attracted companies of the regional biomedical cluster, such as “MedInzh,” “MedIntell,” “MedInzh-Management,” “Enspiromed,” “Nanomed,” “OsteoFix,” “Cardioplant,” “MedInzh-Bio,” “Endocarbon,” and more.
The workshop was led by Evgeny Rogov, head of clinical studies control department at Roszdravnadzor, and members of the Center of Monitoring and Clinical-Financial Inspection: Valeriya Lyadova, head of inspection and safety monitoring of medical products, and Vitaliy Dudik, head of legal and HR management department.
The workshop participants reviewed the legal acts that govern over the medical product market in Russia, and held a detailed review of quality inspection procedures, requirements for effectiveness and safety of medical products, along with a review of most common mistakes while filing paperwork.
A separate workshop held during the event was dedicated to the newly returned stock list classification of medical products.
The companies and individuals taking part in the event were able to discuss the topics as well.
The workshop was very important for Penza enterprises that have developed new medical products, Sergei Evdokimov, chairman of “BioMed” engineering and production cluster, managing director of “MedInzh,” told PenzaNews agency.
“It’s no secret that every medical product goes through a fairly complicated registration procedure before becoming available on the market. More importantly, the procedure is new: it was introduced quite recently, and enterprises have no experience with it yet. Because of that, and to reduce mistakes and help speed up the registration process, our cluster asked Rospotrebnadzor to explain the legal changes and paperwork requirements,” he said.
According to him, such workshop aim to help product registration go smoothly in all stages.
“We will be talking about registering new heart valve prosthetics, and new artificial joints, so these are mostly implants. Most vitally, we were allowed to conduct medical tests of coronary and vascular stents. It is a very hot issue,” Sergei Evdokimov stressed.
A similar point of view was held by managing director of “Enspiromed” Denis Timirbaev, who noted that the workshop provides an opportunity to gain otherwise unavailable information.
“We have two large products: intratracheal tubes for treating children, and a small-scale tracheostomy set. We have received a permission to hold their clinical tests,” the speaker explained.
According to him, the education course will provide Penza professionals with a unique opportunity to learn more about complicated procedures.
“If this goes well, we will all see how many new medical products will originate from Penza by the end of the year,” he concluded.