NOTICIAS

The MHRA has published its ‘GxP data integrity guide’

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

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

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

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 Guidance

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

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

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...

Is an orphan medicine still an orphan once it gets on the market?

Is an orphan medicine still an orphan once it gets on the market?

EMA publishes additional reports on decision-making for orphan medicines, an initiative that addresses requests from stakeholders. The new reports summarise the reasoning of the Agency’s Committee for Orphan Medicinal Products (COMP) on whether or not a medicine...

FDA Drafts PRV Guidance for Medical Countermeasures

This guidance provides information on implementation of section 3086 of the 21st Century Cures Act (Cures Act) (Public Law 114-255), which added section 565A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-4a). Section 565A of the FD&C...

Nova Creditação OF para o curso: Boas Práticas de Fabrico . GMP 2018

Nova Creditação OF para o curso: Boas Práticas de Fabrico . GMP 2018

O curso Boas Práticas de Fabrico GMP 2018 para o próximo dia 30 de janeiro de 2018, conduzido pela reputada formadora Drª Fernanda Ralha, do Infarmed, foi creditado com 0.563 CDP   Nesta formação tem a oportunidade de ver abordados assuntos como : Novos conceitos...

AVALIAÇÃO CLÍNICA de PRODUTOS de SAÚDE  Lisboa, 17 de abril de 2018

AVALIAÇÃO CLÍNICA de PRODUTOS de SAÚDE Lisboa, 17 de abril de 2018

Apresentamos a 2ª edição da formação AVALIAÇÃO CLÍNICA de PRODUTOS de SAÚDE, para o dia  17 de abril de 2018, conduzido pela reputada especialista Dra. Sónia Ferreira,Diretora Técnica.Diretora de Qualidade.Responsável de Farmacovigilância, da A. MARTINS &...

Actualização nas BOAS PRATICAS DE FARMACOVIGILÂNCIA

Actualização nas BOAS PRATICAS DE FARMACOVIGILÂNCIA

Final GVP modules Document(s) Language Status First published Last updated Effective Date Guideline on good pharmacovigilance practices: Module I – Pharmacovigilancesystems and their quality systems (English only) adopted 25/06/2012 02/07/2012 Guideline on good...

PGEU Best Practice Paper: Pharmacovigilance and Risk Minimisation

PGEU Best Practice Paper: Pharmacovigilance and Risk Minimisation

This best practice paper outlines the evolution of pharmacovigilance in Europe, particularly in the context of the fifth anniversary of the 2012 EU pharmacovigilance legislation and recent developments in the field. Additionally, this paper describes the varied role...

Refuse to File: NDA and BLA Submissions to CDER

The purpose of this guidance is to clarify circumstances under which the FDA’s Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or supplemental NDA (21 CFR 314.101(d)) or a biologics license application (BLA) or...

FDA promotes faster digital health regulation

The purpose of this guidance is to identify the types of decision support software functionalities  that: (1) do not meet the definition of a device as amended by the Cures Act; (2) may meet the  definition of a device but for which FDA does not intend to enforce...