Carla Bacchin Fernandes de Moraes Cox joined the Firm in 2012. Her practice areas include Public Law and Regulatory, with focus on consultancy and administrative litigation matters. Assist clients in the regulatory area, especially pharmaceutical, medical devices and health areas, with practice before the National Health of Surveillance Agency (ANVISA), National Research Ethics Commission – CONEP, Drugs Market Regulation Chamber – CMED, Ministry of Agriculture, State Health Secretariats and local health authorities. Prepares legal opinions and responds to consultations on the areas of expertise, including public tenders and contracts with the government. In addition, Carla is a member of the Bioethics and Biolaw Commission of OAB/SP.
She graduated from Universidade Presbiteriana Mackenzie with a degree in Law, and has a specialization in “Public Law” at Escola Paulista de Magistratura.
Co-author of several books/articles, such as:
– the chapter related to Brazil in “Healthcare Enforcement & Litigation”, published by Getting the Deal Through (2016) – (co-author);
– chapters related to Brazil in “The Pharma Legal Handbook – Brazil. PharmaBoardroom,” (2018 and 2021) – (co-author).
Portuguese and English.
Trench Rossi Watanabe is awarded the CESA Gender Equality Seal
Trench Rossi Watanabe has received the CESA Gender Equity Seal in the highest category entitled “Highlight”. This award recognizes law firms that have solid Diversity, Equity and Inclusion initiatives, taking into consideration several fronts, such as internal commitment, strategic planning, communication and participation rate. With a female majority in leadership for years, this recognition reinforces […]
ANVISA regulates Software as a Medical Device (Software as Medical SaMD)
In brief The National Health Surveillance Agency (“ANVISA”) published yesterday in the Official Gazette the Resolution RDC No. 657/2022, which provides for the regularization of software as medical device (SaMD). The topic is part of ANVISA’s 2021-2023 Regulatory Agenda and has been discussed together with society in recent years, especially from the opening of Public […]
National Health of Surveillance Agency publishes a new resolution regarding the recall of drugs
The National Health of Surveillance Agency (“ANVISA”) published today the Resolution RDC No. 625/2022, which provides the minimum requirements related to the obligation of the marketing authorization holders to communicate the implementation of a drug recall to the competent authorities and consumers, in case there is sufficient evidence or proof of quality deviation resulting in […]
Anvisa published new Resolution on Good Practices for the Distribution, Storage and Transport of Drugs
ANVISA published on October 9, in the Official Gazette the new Resolution of the Collegiate Board – RDC nº 430/2020 providing for the Good Practices of Distribution, Storage and Transport of Drugs. This new Resolution revokes Resolution No. 304/2019, which was published almost a year ago, but had not yet entered into force. ANVISA maintained the […]
Published resolution of Good Manufacturing and Importing Practices for Drugs and Pharmaceuticals Inputs
ANVISA published (May 28) the Resolution RDC No. 392/2020 for defining extraordinary and temporary criteria and procedures for flexing certain specific requirements applicable to the Good Manufacturing Practices and Import of Pharmaceutical Inputs, due to the Coronavirus pandemic. According to the RDC, exceptional and temporally, manufacturers and importers of drugs and pharmaceutical inputs may disregard […]