NOTICIAS

Realizou-se no dia 30 de novembro a primeira  edição do workshop exclusivo da Formiventos  sobre a GESTÃO da DISPONIBILIDADE de MEDICAMENTOS,  conduzido por  Helena Ponte, Unidade de Projetos Interinstitucionais e para o Sistema de Saúde da INFARMED Foi uma sessão...

Nos dias 5 e 6 de dezembro   decorreu a formação sobre os  Novos pedidos de AIM :  Uma combinação de teoria e exercícios práticos, para adquirir os  conhecimentos  cruciais para gerir com sucesso a tramitação completa do seus Novos pedidos de AIM O formador, Dr Selmo...

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This document provides detailed guidance on the data elements and associated business rules for the submission of information on medicinal products authorised for veterinary use into the Union Product Database (UPD), as required in Regulation (EU) 2019/6 and...

No 30 de novembro decorreu a formação sobre as  BOAS PRÁTICAS CLÍNICAS : ICH GCP E6 (R3)conduzida pela reconhecida especialista Dra Maria Alexandra Ribeiro, Presidente da CEIC A Formiventos apresentou um curso específico de actualização com o objetivo de efectuar uma...

No passado dia 29 de novembro decorreu mais uma nova edição da formação sobre  PROMOTIONAL REVIEW COMPLIANCE & BEST PRACTICES  conduzido por Sónia Ferreira, Technical Director, RA Manager/ LRPPV, Quality Manager da  GUERBET. A. MARTINS & FERNANDES Uma sessão...

With the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the regulatory framework for medical devices and in vitro diagnostic medical devices (IVD) has significantly changed. The main objectives of these two Regulations are to establish a robust,...

The research driven pharmaceutical industry, represented by EFPIA, strives to improve human health and wellbeing. It is scientifically proven that climate change will adversely impact human health . Therefore, understanding the relationship between people, health and...

The falsification of medical devices is a serious international matter of concern, but little data is available, making it difficult to assess the current state of affairs. To help bridge this gap, the Committee of Experts on Minimising Public Health Risks Posed by...

No dia  29 de novembro , decorreu em  Lisboa a 5ª edição da formação sobre o   CONTROLO DE ALTERAÇÕES, conduzido por  Sara Cunha , CHC & GEM Quality Business Partner, da  Sanofi A Formiventos apresentou esta formação exclusiva para os profissionais da Indústria...

This Q&A document has been created to provide preliminary guidance to CTIS users on how to protect personal data and commercially confidential information (CCI) in CTIS, the EU database established in accordance with the requirements of Regulation (EU) No 536/2014...

No passado dia 22 de novembro decorreu mais uma nova edição da formação sobre  Qualificação de Fornecedores ,Clientes e Entidades Subcontratadas  , conduzida por Teresa Cruz , da MTA Pharma Nesta formação foram revistos todos os passos do  processo da qualificação :...

This guide has been produced to show applicants how to use the IRISplatform to prepare and submit an #application and/or data for a #scientificprocedure (orphan designation application, scientific advice,ITF briefing meeting requests, PRIME, marketing status reports,...

Better healthcare with portability rights The law would give patients the right to access their personal health data across the EU’s different healthcare systems (so-called primary use), and allow health professionals to access data on their patients. Access would...

ISO/IEC 17021-1 is an International Standard that sets out the general requirements for bodies operating audit and certification of organizations’ management systems. If such bodies are to be accredited as complying with ISO/IEC 17021-1 with the objective of auditing...

Nos dias 22 e 23 de novembro teve lugar a  edição número 20 da formação sobre as BOAS PRÁTICAS de DISTRIBUIÇÃO de medicamentos de uso humano e de substâncias ativas; uma formação dinâmica, super interessante donde são abordados os temas de forma prática e concisa e...

Much has been written on cybersecurity generally and on medical device cybersecurity more specifically; however, the latter is a matter of relatively recent regulation in the EU. In some of our previous work,2 we set out the existing legal framework on cybersecurity,...

De acordo com os dados da EMA, mais de 40% das submissões requerem ser revistas. As deficiências mais comuns são as relativas ao preenchimento dos formulários, a deficiências na classificação das alterações e à falta de documentação de suporte (não justificação das...

Realizou-se no dia 21  de novembro a segunda  edição do workshop exclusivo da Formiventos sobre  Aprovação, Formação e Revisão anual de PREÇOS de MEDICAMENTOS  conduzido pela excelente formadora Dra Jalmira Mulchande, Senior Consultant da PHARMAISSUES Este programa...

The revised Annex 1 of the EU GMP Guideline, came into force on August 25th, 2023. The revised Annex 1 of the PIC/S GMP Guideline (PE 009) on the manufacture of sterile medicinal products was adopted by the PIC/S Committee on September 9, 2022 and came into force on...

MedTech Europe and its members fully support the objectives of the medical technology regulations IVDR and MDR to establish a “robust, transparent, predictable and sustainable regulatory framework for [in vitro diagnostic] medical devices which ensures a high level of...

The primary purpose of this IMDRF guidance is to recommend a harmonized approach for the application of existing regulatory pathways to medical devices that are intended for a particular individual, and to identify special considerations for the regulation of each...

Questions and answers are being updated continuously and will be marked by “NEW” or “Rev.” with the relevant date upon publication. This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation...

This guidance is intended to assist owners or operators of cosmetic product facilities that are subject to the requirements related to facility registration and responsible persons that are subject to the requirements related to cosmetic product listing under the...

News 08/11/2023 The Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across the European Union (EU). The product information of a...

Apresentamos-lhe a edição número 2 da formação sobre "Aprovação, Formação e Revisão anual de PREÇOS de MEDICAMENTOS" que vai decorrer no próximo dia 21 de novembro em Lisboa . Um guia completo para o desenvolvimento da estratégia de pedido de preço de medicamentos, e...

  The EU Commission has today published 'Notified Bodies Survey on certifications and applications (MDR/IVDR) Survey results with data status 30 June 2023 (medium and small dataset)' The aim of the study is to support monitoring and analyzing the availability of...

The WHO Classification of digital interventions, services and applications in health (CDISAH) categorizes the different ways in which digital health interventions used in digital applications and services are used to address individual and health sector needs and...

Europe takes great pride in its robust social security systems and the fundamental principles of equitable healthcare access. Medical technologies form an integral part of such quality healthcare and are crucial for all stages of the patient journey, from prevention...

The European Medicines Agency EMA has published a so called "MSSG Toolkit on recommendations on tackling shortages of medicinal products", a guidance document for use by the MSSG to facilitate identification of recommendations on critical shortages of medicinal...

“Formação de excelência sobre publicidade de Suplementos Alimentares com exemplos práticos que refletem muito bem o que se deve e o que não se deve fazer . “ PHARMAFFAIRS   “Como sempre acontece nas sessões da Formiventos, foi mais uma excelente oportunidade de...

The Commission has adopted today a set of actions to better prevent and mitigate critical medicine shortages in the EU, this winter, next winter and beyond. Recent critical shortages, including of certain antibiotics last winter, show that continued coordinated action...

Today, EMA published  details of the newly created solidarity mechanism developed by the EMA Medicines Shortages Steering Group (MSSG). This voluntary mechanism allows Member States to support each other in the face of a critical medicine shortage. The solidarity...

The EU Commission has today published a Draft EUDAMED RoadMap with updated timelines for each module and mandatory use dates. Q4 2027: Actor, Certificates, MSU, Vigilance and CI/PS (MDR Article 123(3) (d) ) / (IVDR Article 113(3) (f)) Q2 2029: Devices and Certificates...

The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Food and Drug Administration...

“Excelente partilha de dúvidas e situações reais entre os participantes e a formadora. “. PLURAL   Realizou-se na quarta-feira passada a formação  sobre a VALIDAÇÃO de TRANSPORTE em ambiente BPD  bajo o lema " Elaboração, revisão e aprovação do protocolo de...

The World Health Organization (WHO) has released a new publication listing key regulatory considerations on artificial intelligence (AI) for health. The publication emphasizes the importance of establishing AI systems’ safety and effectiveness, rapidly making...

Software has become an increasingly important part of the medical device landscape. It is estimated that one in four medical devices either incorporate medical device software (MDSW)1 or are MDSW in their own right. With the broad public use of smart phones and...

The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket regulatory decisions that the Food and Drug Administration...

The guideline specifically concerns bacteriophage products for prophylactic, metaphylactic and/or therapeutic treatment of one or more specific bacterial infection(s) or infectious disease(s) caused by bacteria, or dysbiotic conditions, where efficacy of treatment is...

MedTech Europe has developed this interactive Data Hub to provide the most relevant and up-to-date insights regarding the state of the medical technology industry. Capturing the activity of the medical technology industry is vital for healthcare stakeholders, business...

This guidance document provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This document is intended to be used in conjunction with information regarding the content...

Since the launch of CTIS in 2022, the deferral functionalities have proven to be complex from an information management and data security perspective, which has led to some uncertainties in the use of CTIS when deferrals were applied. The deferral functionality,...

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is today publishing its official response to the draft Pharmaceutical Legislation [published 26 April]. It reiterates Industry’s view that the proposals, in their current form, would harm...

  Table of contents Reprocessing (3.2.S.2.2, 3.2.P.3.3) Raw materials and media components (3.2.S.2.3) Method identification numbers (3.2.S.4.1, 3.2.P.5.1) Process validation, removal of process related impurities, process related impurities testing (3.2.S.2.5,...

This guidance provides the standards for the submission of premarket notification (510(k)) submissions by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory...

This integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the pre-submission guidance for access to the hyperlinked information. Questions and answers are being updated continuously and...

Having multiple different strengths of a drug product available in ready-to-use containers from which the entire drug content of the container(s) is administered to the patient may simplify the preparation and administration of a drug compared to preparing and...

FDA has interpreted this substantial evidence requirement as generally requiring two adequate 44 and well-controlled clinical investigations, each convincing on its own, to establish effectiveness.  Nevertheless, as noted in the 1998 Effectiveness guidance, FDA has...

FDA is issuing this draft guidance document to introduces submitters of De Novo requests to the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research to the current resources and associated content developed and made publicly...