Events & Courses
February 2019
A New Full-Day Course by NetValue BioConsulting Inc.:
Medical Devices – Implementation of the New Requirements of Health Canada
Navigating the Regulatory and Quality (MDSAP) Pathways
- Canadian regulatory requirements for approval of medical devices including products approved in other jurisdictions
- Preparation for and compliance with the new Canadian regulatory requirements for medical devices (transition to MDSAP; ISO 13485:2016)
- Preparation and submission of Pre-ITA, ITA, Licensing application
- Comparison of regulatory requirements in Canadian and other jurisdictions (US, EU)
- Risk management and quality systems requirements
- Regulatory requirements for clinical trials of medical devices
- The advantages of applying for licensing in Canada
December 2016
NetValue BioConsulting Inc. was proud to co-organize and participate in the Seminar “Canada and Israel – Enhancing Biomedical Development and Clinical Trials”, which was held on December 14th, 2016 at the Crowne Plaza Hotel in Tel Aviv. We wish to thank the Canadian Embassy in Israel and their staff, for sponsoring and for the hard work put into organizing this successful event.
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Opening remarks were given by her Excellency Deborah Lyons, Ambassador of Canada to Israel, who stated that Canada has the second lowest cost for clinical trials, 30% less than in the United States.
Dr. Gina Coleman, Chief, Clinical Evaluation Division, Centre for Biologics Evaluation, Biologics and Genetic Therapy Directorate – Health Canada, spoke about “The Canadian Regulatory Environment: Regulations, Organization and Flexibilities in Implementation”. Link to Presentation
Mr. Les Szendrovits, Partner at NetValue BioConsulting Inc. spoke about the sponsor’s perspective of regulatory development in Canada. Link to Presentation
Ms. Victoria Nahary, Managing Director World Courier Israel, gave a very practical and useful presentation the logistics and shipping challenges of personalized medicine products. Link to Presentation 
Dr. Rafi Hofstein President & CEO MaRS Innovation, Board Member Clinical Trials Ontario, spoke about The Unique Advantages of Conducting Clinical Trials in Ontario and Canada. Link to Presentation
Dr. Valentin Fulga Co-Managing Partner NetValue BioConsulting, summarized the event with his presentation. It outlined the challenges and other points to consider in the development of Life Science Products in a multinational environment. Link to Presentation
Ms. Tali Rahinstein, Head of Business Development at Bioforum described their collaboration with a Canadian organization as an example of a new partnerships between a Canadian and an Israeli Life Sciences company.
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September 2016
Dr. Valentin Fulga’s lecture at Life Science Baltics Conference on Sept 13, 2016, titled, “Regenebank – A multifaceted approach to solve major health challenges” was received with great interest. The novel collaborative model encompassing representatives from the government, academia and the private enterprise to develop a central bio-bank led to animated discussions with representatives from organization from several countries.
August 2016
August 10, 2016 – Dr. Valentin Fulga, co-Managing Partner of NetValue BioConsulting was invited to speak at the 3rd Life Science Baltics Conference, an international forum dedicated to biotechnology, pharmaceuticals and medical devices. Dr. Fulga will be one of the speakers at the Regenerative Medicine Session. His lecture, titled “Regenebank – A multifaceted approach to solve major health challenges” will focus on new sources of regenerative tissues that can be banked and a novel collaborative model of biobanking.