NOTICIAS

FDA Medical Devices Safety Action Plan

The Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health outlines a vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices throughout the TPLC, to provide for the timely communication...

FDA NEW GUIDANCE on Special Protocol Assessment

This guidance provides information on the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for special protocol assessment (SPA). SPA is a process in which...

BENEFIT-RISK ASSESSMENT IN DRUG REGULATORY DECISION-MAKING

Draft PDUFA VI Implementation Plan (FY 2018-2022) MARCH 30, 2018 U.S. FOOD AND DRUG ADMINISTRATION   As part of the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) under Title 1 of the FDA Reauthorization Act of 2017, FDA committed to furthering...

Conclusões da 3ª edição do curso “QUALIFIED PERSON”

A Formiventos celebrou no dia 23 de maio a 2ª Edição do Curso : QUALIFIED PERSON , conduzido pela reputada especialista Dra Fernanda Ralha, Diretora. Direçaõ de inspeção e Licenciamento do INFARMED; bajo o lema "Uma revisão do impacto das novas Regulamentações nas...

The MHRA has published its ‘GxP data integrity guide’

The way regulatory data is generated has continued to evolve in line with the ongoing development of supporting technologies such as the increasing use of electronic data capture, automation of systems and use of remote technologies; and the increased complexity of...

Submitting risk management plans on the new EU template: 3 tips

Published  by pharmaphorum.com Are you prepared for the upcoming changeover to the new EU risk management plan (RMP) template? Seema Jaitly offers some timely guidance on the new EU RMP document. DOWNLOAD About the author: Dr Seema Jaitly qualified in Medicine from...

RESUMO DA 2ª EDIÇÃO DO REGULATORY DAY

No passado dia 27 de Fevereiro teve lugar o 2º Fórum The Regulatory Community in Action, no hotel Novotel, onde participaram mais de 60 participantes com largo conhecimento e experiência na área regulamentar da Indústria Farmacêutica. Com uma plateia repleta e com...

New guidance on processing of applications for regulated products

An administrative guidance published today sets out the principles that EFSA follows when processing applications for regulated products. This is part of EFSA’s continuous efforts to support applicants throughout the life-cycle of their applications. The guidance...

DATA INTEGRITY REFERENCES

REFERÊNCIAS: .-EMA: Questions and answers: Good manufacturing practice - Data Integrity Section .-FDA: FDA Data Integrity Guidance .-MHRA: MHRA Data Integrity Definitions and Guidance .-PIC/S: PIC/S Guidance .-WHO: WHO...

Data Standards Strategy FY2018-FY2022

The purpose of the CBER-CDER Data Standards Strategy is to reinforce the ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the pre- and postmarket regulatory review process so that...

Monitoring, Analyzing and Interpreting Regulatory Trends

Posted 24 January 2018 | By João Duarte Regulatory Focus. January 2018. Regulatory Affairs Professionals Society. This article discusses ways in which the regulatory intelligence professional can monitor, identify, analyze, interpret and "stay on top" of regulatory...

TELLING STORIES: HOW LEADERS CAN INFLUENCE, TEACH, AND INSPIRE

Telling Stories: How Leaders Can Influence, Teach, and Inspire Vanessa Boris and Lani Peterson December 2017 • Harvard Business Publishing Part of the work of a leader is to influence—to teach, convince,and inspire those around them. That includes their staffs, their...

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