NOTICIAS
AMA Future of Health: The Emerging Landscape of Augmented Intelligence in Health Care
The AMA is committed to ensuring that the evolution of augmented intelligence (AI) in medicine benefits patients, physicians and the health care community by leading the way. This includes: Developing AI principles for the use of AI in health care. Supporting the...
BOAS PRÁTICAS de DISTRIBUIÇÃO de DISPOSITIVOS MEDICOS: “Muito útil para a minha área de trabalho. Fantástico !!
Decorreu mais uma edição da formação sobre BOAS PRÁTICAS de DISTRIBUIÇÃO de DISPOSITIVOS MEDICOS uma formação dinâmica, super interessante donde foram abordados os temas de forma prática e concisa e adaptadas às várias realidades . Ao longo das 14 horas de...
Updated document – Notified Bodies Survey on certifications and applications (MDR/IVDR)
The European Commission has today (13-March) published the updated document of the "Notified Bodies Survey on certifications and applications (MDR/IVDR) survey results of the 6th NB survey with data status 31 October 2023" As a result of further data validation...
EU Commission launches the first public consultation on Health Technology Assessment (HTA) Implementing Regulation
The European Commission has just launched an online public consultation on the draft Implementing Act on Joint Clinical Assessments of Medicinal Products. The consultation is to run for four weeks, until April 2. Emphasis on the rules on HTA (Regulation 2021/2282)...
MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024)
The clinical investigation plan (CIP) shall set out the rationale, objectives, design methodology, monitoring, conduct, record-keeping, and the method of analysis for the clinical investigation. The CIP should be detailed enough to serve as a manual for investigators...
EudraVigilance – EVWEB User Manual
This user manual is part of the official documentation prepared by the European Medicines Agency to support the use of the EudraVigilanceWebreportingtool (EVWEB). The user manual consists of 5 chapters. Chapter 1 presents a comprehensive overview of the EVWEB...
EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance
The undersigned Qualified person responsible for pharmacovigilance (QPPV)/responsible person (RP) declares that he/she: • will keep the username and password provided by the European Medicines Agency (EMA) for the access to the EudraVigilance database under an...
Regulamento que aprova boas práticas de publicidade a medicamentos não sujeitos a receita médica através de canais digitais
Com o desenvolvimento das redes sociais, a publicidade digital assumiu proporções gigantescas, que exigem especial atenção quando se trata de produtos, como é o caso dos medicamentos, ainda que não dependentes de uma prescrição médica para a sua utilização. Assim, nos...
EU MDR/IVDR News (Harmonised Standards)
The European Commission has published two Implementing Decisions regarding medical device harmonised standards. "Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for...
GMP 2024: BOAS PRÁTICAS DE FABRICO: “O conhecimento técnico e exemplos práticos da formadora fizeram a diferença
Realizou-se na quarta-feira passada uma nova edição da formação GMP 2024: BOAS PRÁTICAS DE FABRICO , especialmente desenhada para profissionais que querem ampliar e atualizar os seus conhecimentos e saber como melhor cumprir os novos requisitos legais...
ICH Q2(R2) Guideline on validation of analytical procedures . Step 5 . Date for coming into effect 14 June 2024
This guideline presents elements for consideration during the validation of analytical procedures included as part of registration applications. Analytical procedure validation forms a part of the analytical procedure lifecycle, as described within ICH Q14 Analytical...
Workshop NOTIFICAÇÃO E ALEGAÇÕES de SUPLEMENTOS ALIMENTARES : “Evento excelente para aprendizagem e troca de ideias em âmbito regulamentar.”
Decorreu mais um workshop prático sobre NOTIFICAÇÃO E ALEGAÇÕES de SUPLEMENTOS ALIMENTARES com exemplos práticos Usando uma combinação de teoria e exercícios práticos, a formadora , Rita Dias, Especialista em Registo e introdução no mercado de suplementos...
Public consultation on implementing the EU Health Technology Assessment Regulation
Today, the European Commission launched an online public consultation on the draft Implementing Act on Joint Clinical Assessments of Medicinal Products. This online consultation remains open for responses until 2 April 2024. We invite all interested individuals and...
Retirada do PVP das embalagens e Revisão Anual de Preços de Medicamentos 2024
O cumprimento das obrigações previstas para a comercialização dos medicamentos em consonância com as normas em vigor é uma responsabilidade partilhada entre todos os agentes do circuito, sendo inadmissíveis situações que possam colocar problemas no abastecimento do...
ICH Q14 Analytical procedure development – Scientific guideline
This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products. It applies to new or revised analytical procedures used for release...
The ICH Q3C(R9) Guideline reaches Step 4 of the ICH Process
The ICH Q3C(R9) “Guideline for Residual Solvents” was revised using the ICH Minor Revision Procedure and reached Step 4 of the ICH Process on 24 January 2024. This minor revision was implemented to include consideration of solvent volatility for analytical methods....
GDP Nível 2 : Mais uma edição marcada pelo sucesso em termos de utilidade e relevancia para os formandos
Ontem, tivemos o prazer de realizar uma nova edição da formação exclusiva da FORMIVENTOS sobre as BOAS PRÁTICAS DE DISTRIBUIÇÃO , NÍVEL AVANÇADO, bajo o lema " uma formação de refreshing nas Boas Práticas de Distribuição de Medicamentos, à luz da formacão contínua...
CAPAS 2024 : “Exemplos excelentes e significativos vs legislação e teoria. Bem explicados!
“A formação representa um overview completo e claro do processo CAPA. “ GRUNENTHAL Decorreu no dia 21 de fevereiro a 3ª edição da formação exclusiva da Formiventos sobre : Como implementar, manter e rever o Sistema CAPA, conduzido por Marta Monteiro , Global...
Novos catálogos eletrónicos HMA-EMA de fontes de dados do mundo real e estudos
A Agência Europeia de Medicamentos (EMA na sigla em inglês) e a Autoridade Europeia para Medicamentos (HMA na sigla em inglês) lançaram dois novos catálogos eletrónicos sobre fontes de dados do mundo real e estudos para apoiar reguladores, investigadores e empresas a...
Medical devices: Council endorses new measures to help prevent shortages
The Council has endorsed key updates to the law on medical devices that will help prevent shortages and ease the transition to greater transparency and access to information. The regulation approved by EU member-state representatives today amends the legislation on...
Charging for Investigational Drugs Under an IND: Questions and Answers
This guidance addresses frequently asked questions related to the implementation of FDA’s regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment...
FDA final rule to amend the device current good manufacturing practice requirements to harmonize and modernize the regulation
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to align...
EUDAMED user guide Economic Operators – Actor module
EUDAMED is the IT system developed by the European Commission to implement the EU medical devices regulations: Regulation 2017/745 on medical devices Regulation 2017/746 on in vitro diagnosis devices EUDAMED is structured around six interconnected modules and a...
Portaria n.º 51/2024, de 15 de fevereiro : Regras de formatação das informações obrigatórias sobre o preços dos medicamentos
Com a publicação do Decreto-Lei n.º 128/2023, de 26 de dezembro, foi aprovada a retirada do preço das embalagens dos medicamentos que estava prevista no Decreto-Lei n.º 176/2006, de 30 de agosto, na sua redação atual, mantendo-se, porém, a obrigação de, no momento da...
Launch of new HMA-EMA catalogues of real-world data sources and studies
15 February 2024 EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues: one for real-world data (RWD) sources and one forWD studies. The catalogues help medicines regulators, researchers and pharmaceutical companies to identify...
EU MDR Transition –Recalls and market notifications
TGA have been published new document very helpful and interesting about EU MDR Transition –Recalls and market notifications Case studies and scenarios Version2.1,February2024 Introduction This guidance covers case studies and scenarios about recalls and market...
ICH E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of individual Case Safety Reports
ICH JUST RELEASED ‼️ It is important to establish an internationally standardised procedure to ensure the quality of post3 approval safety information and to harmonise, where feasible, the way of gathering and reporting information. The ICH E2D guideline...
EDQM pre-publishes Ph. Eur. Cannabis Flower Monograph
The new monograph on Cannabis flower (3028) was adopted at the 176th session of the European Pharmacopoeia (Ph. Eur.) Commission held on 20 and 21 June 2023. Given the exceptionally high interest from stakeholders in having access to the new text as soon as possible,...
Use of Data Monitoring Committees in Clinical Trials
This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB), a data and safety monitoring committee (DSMC), or an independent data monitoring committee...
Conducting Remote Regulatory Assessments Questions and Answers
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Conducting Remote Regulatory Assessments--Question and Answers.” FDA is issuing the draft guidance to describe the Agency’s current thinking...
UPDATED Glossary of ICH terms and definitions
Version 5, 7 February 2024 -- This glossary combines the terms and definitions included in the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It was compiled by CIOMS from the...
Transição de ensaios clínicos deve decorrer no prazo máximo de um ano
O dia 31 de janeiro de 2024, marca os dois anos de entrada em aplicação do Regulamento Europeu de Ensaios Clínicos (CTR), e do lançamento do Sistema de Informação de Ensaios Clínicos (CTIS). Assinala-se o aproximar do fim do período de transição para CTR/CTIS dos...
What to expect from medtech in 2024
The medtech industry posted an uneven year in 2023. Among the reasons for celebration were expectation-beating revenue growth, a record number of novel-product approvals, and a spate of divestitures that helped companies refocus on their core capabilities. On...
Updated document – Notified Bodies Survey on certifications and applications (MDR/IVDR)
NB NEWS: The results of the 6th Notified Bodies Survey on certifications and applications (MDR/IVDR) have just been published 5 Febuary 2024.
MDCG 2024-2 Procedures for the updates of the European Medical Device Nomenclature
The European Medical Device Nomenclature (EMDN), as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 - In Vitro Diagnostic medical devices Regulation (IVDR), will be annually reviewed...
New EU MDCG Guidance on Medical Device Vigilance Requirements
A large release of the Medical Device Coordination Group (MDCG) Guidance on Vigilance has been published to the European Commission website: MDCG 2024-1, MDCG 2024-1-1, MDCG 2024-1-2, MDCG 2024-1-3, and MDCG 2024-1-4. Each guidance falls into the “Device Specific...
Guidance International Recognition Procedure
From 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the new International Recognition procedure (IRP). The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be incorporated under the umbrella of IRP. ECDRP and MRDCRP...
Medical Device Software: Considerations for Device and Risk Characterization
Consultation open Medical Device Software: Considerations for Device and Risk Characterization Start date Friday, 2 February 2024 Closing date Thursday, 2 May 2024 A Proposed Document by the International Medical Device Regulators Forum (IMDRF), Software as a...
What to expect in US healthcare in 2024 and beyond
A new perspective on how technology, transformation efforts, and other changes have affected payers, health systems, healthcare services and technology, and pharmacy services The acute strain from labor shortages, inflation, and endemic COVID-19 on the...
Quality assurance of pharmaceuticals: a compendium of guidelines and related materials: volume 2: Good manufacturing practices and inspection, 10th ed
The World Health Organization (WHO) developed the Quality Assurance of Pharmaceuticals Compendium, Volume 2, to ensure the quality, safety and effectiveness of medicines, focusing on good manufacturing practices (GMP) and related guidelines. This summary provides an...
FDA Quality and Compliance (Medical Devices)
The FDA issued the Quality Management System Regulation (QMSR) Final Rule, which amends the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating the international standard specific for...
IAF Medical Device Nomenclature (IAF MDN) Including Medical Device Risk Classifications
This IAF Medical Device Nomenclature document (IAF MDN) is an informative document that was developed for the support of IAF MD8 and MD9. It provides long established medical device names and classifications, where risk classifications do not exist in the Global...
Overview of language requirements for manufacturers of medical devices
The Commission and Member States have created MDR and IVDR tables. These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and medium-sized ones, understand the language requirements for the information and...
Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP)
Update: January 31, 2024 The FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating by reference the...
New MDCG Jan. 2024 Post-Market Surveillance and Vigilance (PMSV).
Five new mdcg files read the full thread. 1. MDCG 2024-1 Guidance on the vigilance system for CE-marked devices Source: https://lnkd.in/gKC3KPaD 2. MDCG 2024-1-1 DSVG 01 on Cardiac ablation Source: https://lnkd.in/gKM9RuCH 3. MDCG 2024-1-2 Guidance on the...
Boas Práticas de Fabrico Nível avançado: ” Muito interessante e proveitoso “
Decorreu no dia 25 de janeiro a formação exclusiva da Formiventos sobre as Boas Práticas de Fabrico :Nível avançado; uma sessão de aprofundamento, actualização e revisão das Novidades GMP, conduzida pela reconhecida especialista, Dra Teresa Cruz da MTA Pharma...
Impact of the EU’s General Pharmaceutical Legislation on Europe’s Innovation Ecosystem and Biotechnology Companies
Today EuropaBio - the European Association for Bioindustries and Charles River Associates launch the new study “Impact of the EU’s General Pharmaceutical Legislation on Europe’s Innovation Ecosystem and Biotechnology Companies”! This new study highlights the...
EU MDR/IVDR News!! (Eudamed and IVDR Extension)
Today (23-Jan) the European Commission has published a Proposal for "Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption...
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS 2021/0106(COD) DRAFT Final draft as updated on...
Major update of the SME user guide
The revised user guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use. It follows the chronological stages of medicine development,...
US Healthcare Outlook: Strategic Insights into Profit Pools, Value-Based Care, and Technological Advances
The US healthcare industry faces demanding conditions in 2023, including recessionary pressure, continuing high inflation rates, labor shortages, and endemic COVID-19. But players are not standing still. We expect accelerated improvement efforts to help the industry...