Clinical Research: Anvisa creates Technical Chamber for Clinical Research on Medicines and Medical Devices
By Bruna Morais Conceição, André Lins e Bernadete de Figueiredo Dias
On September 13, 2024, Joint Ordinance No. 2 of September 9, 2024, was published, establishing the creation of the Technical Chamber for Clinical Research on Medicines and Medical Devices (“Catepec”).
Catepec will deal with a wide variety of topics, including real-world evidence, pharmacometrics, herbal medicines, vaccines and advanced clinical studies. These topics will have diverse applications in specialties such as pediatrics, dermatology, oncology, cardiology, infectology, neurology, ophthalmology, immunology, clinical pharmacy, among others.
Objectives
Catepec’s objective is to provide technical and scientific support to Anvisa’s Coordination of Clinical Research into Medicines and Biological Products (COPEC/DIRE2) and the Coordination of Clinical Research into Health Products (CPPRO/GGTPS/DIRE3).
In addition, Catepec’s purpose is to monitor scientific and technological advances in the field of health surveillance to modernize, rationalize and streamline Anvisa’s regulatory work in the control of clinical research to support the registration and post-registration of medicines and medical devices.
Catepec also aims to promote the participation of the scientific community in the field of health surveillance and regulation through the exchange of knowledge and experiences.
Collegiate
Catepec will act as a consultative collegiate body, specialized in clinical research. Its members, selected through a call for tenders, will have relevant technical expertise for evaluating clinical trial protocols. The knowledge generated by Catepec will contribute to regulatory decision-making and to the participation of external agents in the decision-making process.
Ordinary meetings of the collegiate body will take place every quarter, while extraordinary meetings will be called by the Catepec Coordinator at least 15 days in advance.
Selection process
With the publication of Joint Call Notice No. 2, dated September 9, 2024, Anvisa opened a selection process to identify professionals interested in joining Catepec, forming a database of CVs. Those selected will be able to join the chamber for a period of three years, as members of working groups or as invited experts at specific meetings.
Those interested in joining the CV database have 30 days from the publication of the notice in the Federal Official Gazette, September 13, 2024, to fill in an electronic form, attaching their updated Lattes CV or regular CV. Representatives of professional or scientific organizations must submit a letter of nomination from the institution, justifying their candidacy and how their skills meet the established criteria.
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