Management of Intellectual Property and Regulatory Issues in Clinical and Translation Research

MANAGEMENT OF INTELLECTUAL PROPERTY AND REGULATORY ISSUES IN CLINICAL AND TRANSLATIONAL RESEARCH

The IB2 Marie Curie Network, the BiotechHealth FCT-PhD Programme, the NanoValor project and Health Cluster Portugal will promote, on the 7th of April 2014, the workshop "Management of Intellectual Property and Regulatory Issues in Translational and Clinical Research", in a collaboration with Infarmed and INPI (Instituto Nacional da Propriedade Intelectual).

The morning session will be held at ICBAS (Amphitheatre 7) and the afternoon session will be at Hospital Santo António (Circular Auditorium), Porto, Portugal

Organised by Health Cluster Portugal with the collaboration of INEB

This initiative intends to foster awareness on issues that are crucial for the translation of research results into clinical applications. Its target audience are: researchers, health professionals, entrepreneurs, R&D managers, the areas of technology transfer and other legal/regulatory functions related to Health.

Target audience: The hands-on workshop will be open to researchers, health professionals, entrepreneurs, R&D managers and technology transfer professionals (in addition to the IB² fellows).

PROGRAMME (sessions in English)

09H30 | Module 1: Industrial Property and technology rights  
Dr. Nuno Pedroso (INPI)

Module contents:  1. Industrial Property and inventions: general concepts. 
2. Patentability criteria, limitations regarding the subject and the patent, special cases of patentability (particular emphasis will be given to inventions relating to human health, biotechnology and genes or partial genetic sequences). 
3. The process of filling a patent. Routes of IP protection: National; European; International. Associated costs.
4. Filing a patent application (Pedido Provisório de Patente - PPP) and corresponding requirements. Conversion to PCT phase (pedido definitivo) and amendments to technical aspects of the application. Associated costs.

10H45 | Coffee break.

11H00 | Module 2: Search of technological information. Databases in the Biotechnology field
Dr. Nuno Pedroso (INPI)

Module contents:  

1. Patent classification.
2. Searches in patent databases. 
3. Searches in biotechnology databases.

13H00 | Lunch (free)

14H00 | Module 3: How to perform clinical trials in Portugal? Practical guidelines for Researchers, Promoters and Clinical Trials Centres  
(Infarmed)

Module contents:

 1. Clinical trials on drugs for humans and clinical studies on medical devices: scientific, legal and regulatory framework. 

2. Perspectives of change in the legal/regulatory framework at national and European levels

3. Practical guidelines for the different stages of clinical trials. 

15H45 | Coffee break

16H00 | Module 4: The circuit of medical devices and medical devices for diagnostics in vitro : overview of legal requirements and proceedings, practical guidelines for the intervening actors
(Infarmed)

Module contents: 

1. Clinical evaluation / Functional evaluation. 
2. Classification and frontiers.
 3. Evaluation of Conformity.
4. Notified body. 
5. Designation authority
6. Launching into the Market. 
7. Registry.
8. Acquisition and Use. 

9. Market Supervision.

17H45 | Closing

REGISTRATION

Those interested in the Workshop must fill in the registration form by the 27th of March 2014.
Since the number of vacancies is limited, the participation in the Workshop will be subject to confirmation.
The participation is free of charge.
All session will be in English.

Co-sponsored by FP7-PEOPLE-2012-ITN-EID IB² - Industrial Biological Biomaterials Doctorate, a Marie Curie Initial Training Network

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