NOTICIAS

New FDA Guidance Answers Questions On RBM Use

This document provides guidance on risk-based approaches to monitoring investigational studies  of human drug and biological products, medical devices, and combinations thereof. This guidance contains recommendations on planning a monitoring approach, developing the...

Factsheet for Manufacturers of Medical Devices

This Factsheet is aimed at manufacturers of medical devices. For a general overview of the impact of the In-VitroMedical Devices Regulation (IVDR) on manufacturers see the Factsheet for manufacturers of in-vitro diagnostic medical devices. References to Annexes and...

FDA Guidance .When a REMS is Necessary

The 10-page guidance explains how the Food and Drug Administration Amendments Act  requires FDA to consider the following six factors in deciding whether to require a REMS:  “The seriousness of any known or potential adverse events that may be related to the drug and...

FRAMEWORK FOR FDA’S REAL-WORLD EVIDENCE PROGRAM

Real world data (RWD) and real world evidence (RWE) are playing an increasing role in health care decisions. FDA uses RWD and RWE to monitor postmarket safety and adverse events and to make regulatory decisions. The health care community is using these data to support...

Making Real-World Evidence More Useful for Decision Making

Real-world evidence (RWE) holds enormous promise, with some of that promise beginning to be realized in the evaluation of harms. However, in order to accomplish major strides in harms assessment, and ultimately in the evaluation of effectiveness, many steps have to be...

Regulatory Science to 2025

The European Medicines Agency's (EMA) draft 'Regulatory Science to 2025' strategy is a plan for advancing EMA's engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. In December 2018, EMA published the draft...

New guidance documents related to a no-deal scenario

MHRA released six  new guidance documents related to a no-deal scenario —five on importing and exporting medicines and active substances, and one on pediatric studies Importing and exporting Importing medicines from an EEA State which is on an approved country for...

MHRA guidance and publications on a possible no deal scenario

Information about the regulation of medicines and medical devices if the UK leaves the EU with no deal. Published 31 January 2019  Last updated 7 March 2019 — see all updates From: Medicines and Healthcare products Regulatory Agency Contents Medical devices...

First guidance on new rules for certain medical devices

 EMA has published today the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices . The new regulations introduce new roles and responsibilities for EMA and national competent...

New online platform for parallel distribution

Source EMA News 11/02/2019 EMA has launched a secure online platform for submitting and managing parallel distribution notifications through the recently implemented IRIS Regulatory & Scientific Information Management Platform. Starting today, 11 February,...

Principles of Premarket Pathways for Combination Products

This guidance presents the current thinking of FDA on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate. This guidance offers general, high-level information relevant to...

Data Integrity and Compliance With Drug CGMP

FDA expects that all data be reliable and accurate (see the “Background” section). CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement  meaningful and effective strategies to...

Electronic product information for human medicines in the EU

In the European Union (EU), a medicine’s product information (PI), which includes the summary of  product characteristics (SmPC, intended for healthcare professionals), labelling (outer and inner  packaging information) and package leaflet (PL, for patients/consumers...

REMS Assessment: Planning and Reporting Guidance for Industry

The US Food and Drug Administration (FDA) on Thursday released two new draft guidance documents aiming to help improve the agency’s ability to ensure that Risk Evaluation and Mitigation Strategies (REMS) put in place for certain drugs and biologics are working...

Communication skills:  Influence & Persuasion with Integrity

Mais uma vez a Formiventos preparou a sua Conferência Anual REGULATORY DAY 2019, o ponto de encontro da comunidade dos profissionais de Regulatory Affairs, Compliance e Qualidade da Indústria Farmacêutica, para fazer o balanço do ano e perspectivar o futuro.   A...

Update to the EU Code of Practice for the Responsible Persons for GDP

The Code of Practice "The Responsible Person for GDP" has been revised, and Version 2 is now available for members of the European GDP Association.  This guidance is applicable to both large and small organisations. In any case, the role of the Responsible Person...

No próximo mês de Fevereiro o 3º Fórum REGULATORY DAY 2019 dá as boas-vindas aos assistentes, oradores e patrocinadores num espaço para partilhar informação, desafios, oportunidades e experiências. https://formiventos.com/project/regulatoryday/ O modelo de negócio...

Creditada pela OF a 3ª edição da Conferência REGULATORY DAY 2019

O próximo dia 27 de fevereiro  terá lugar a 3ª edição da Conferência Conferência Regulatory DAY 2019 , o ponto de reunião dos Regulatorys para partilhar experiências na gestão dos requerimentos regulamentares e nas soluções perante os novos desafios. Nesta 3ª edição ,...

Blockchain Adoption in Pharma Supply

By World Pharma Today Experts have asserted that despite recent developments, pharmaceutical supply chains are still far from reaching their full technological potential. Blockchain holds significant promise to advance the digital strength of medicine supply.  ...

Compliant and profitable: Regulatory Affairs e transformação digital

Com as empresas em contínua mudança devido à prioridade estratégica da  digitalização, manter o crescimento  e manter a   conformidade com os regulamentos torna-se  muitas vezes difícil. Gerir a privacidade dos clientes e doentes, desenvolver a transição para o...