NOTICIAS

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The US Food and Drug Administration (FDA) on Thursday released two new draft guidance documents aiming to help improve the agency’s ability to ensure that Risk Evaluation and Mitigation Strategies (REMS) put in place for certain drugs and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

ICH: Final Concept Paper to ICH Q13 “Continuous Manufacturing“

  The Management Committee of the ICH has endorsed the final concept paper and business plan on the new quality guideline ICH Q13 on continuous manufacturing for drug substances and drug products. Both documents are published on the ICH website. The proposed new...

Regulatory Science to 2025

EMA has published its draft  ‘Regulatory Science to 2025’ strategy for a six-month public consultation . This is a proposed plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary...

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...

Biomarker Qualification: Evidentiary Framework Guidance for Industry

The evidentiary framework described in this guidance identifies the recommended components  of a biomarker development program, including determining the type and level of evidence  sufficient to support qualification, and addresses how these components interrelate to...

FRAMEWORK FOR FDA’S REAL-WORLD EVIDENCE PROGRAM

FDA’s RWE Program will be multifaceted. It will involve demonstration projects, stakeholder engagement, internal processes to bring senior leadership input into the evaluation of RWE and promote shared learning and consistency in applying the framework, and...

Data Management Fundamentals for Your Next Clinical Trial

Data is the most crucial asset in any clinical trial and is used to ultimately drive the decision-making process related to the development candidate. Therefore, for any sponsor, paying close attention to the data management aspects of clinical operations should...

Optimizing Standards for Regulatory Use

Standards play a significant role in the design, production, post-production and regulation of medical devices throughout their lifecycle. Important tools for conformity assessment, standards facilitate and support innovation and help ensure that devices are safe and...

Reflection paper on the qualification of non-genotoxic impurities

The core ICH quality guidelines addressing qualification of NGI are ICH Q3A and Q3B. These guidelines  state that qualification is the process of acquiring and evaluating data that establishes the biological  safety of an individual impurity or a given impurity...

Impact of IVDR on manufacturers of medical devices

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