RESOURCES LIBRARY

Whitepapers, Guidelines, Legislação, Artigos

DATA INTEGRITY REFERENCES

.-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...

Looking to the Future in Regulatory Affairs

By Oliver Cox and Siegfried Schmitt, PhD Predicting the future is, of course, like gazing into a crystal ball; therefore, the reader is warned that the following is based in part on indicators from industry and the regulators, but mostly on personal considerations and...

Good Distribution Practice (GDP) Guidelines

The following Guideline Tree contains the most important Guidelines on Good Distribution Practices (GDP) Good Distribution Practices GDP for Medicinal Products EU Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01 ... Good Distribution...

Legal framework governing medicinal products for human use in the EU

General information The EU legal framework for medicinal products for human use is intended to ensure a high level of public health protection and to promote the functioning of the internal market, with measures which moreover encourage innovation. It is based on the...

First ever guidance for stem cell therapies in animals published

Document gives advice on sterile manufacturing processes for veterinary stem cell medicines The European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) has approved today the first ever guidance at European Union (EU) level for...

Guidelines on good pharmacovigilance practices (GVP)

Introductory cover note, last updated with revision 2 of module V on risk management systems finalised post-public consultation, related revision 2 of module XVI and revision 2 of module II on PSMF   New legislation for pharmacovigilance applies in the European Union...

IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS Q3C(R6)

The core tripartite harmonised ICH Guideline was finalised under Step 4 in July 1997. This recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutical limits for residual solvents (organic volatile...

Cleaning Validation for Pharmaceutical Manufacturing

11 MAY 2017 ALCONOX Cleaning validation is a requirement for pharmaceutical manufacturing, which adheres to current good manufacturing practice (cGMP) and quality systems regulations (QSR). Validation is a documented guarantee that cleaning can be performance reliably...

Insights on Digital Transformation

By Statseeker, The reality is total adoption of IIoT is a ways off and users today need to start the digital transformation for their enterprise to reap benefits before the total technological integration....

White Paper FINANCIAL RISK MANAGEMENT IN TREASURY

A recent SunGard AvantGard study reveals how treasury professionals manage financial risk, from current areas of concern to anticipated challenges. Financial risk management has become a priority in recent years. Tumultuous economic conditions have created new...

Good Distribution Practices Toolkit :Quality Management System

Organization and administration • Regulatory compliance and/or engagement • Approved Suppliers • IT systems • Product Integrity • Self Inspections • Non conformances • Corrective Action and Preventative Action • Validation • Calibration • Change Control • Risk...

What’s new in Pharmacovigilance? QPPV UPDATE

This is the first issue of QPPV Update in 2017. It provides Qualified Persons responsible for Pharmacovigilance (QPPVs) and all other people working in pharmacovigilance with an update on EU Pharmacovigilance Pharmacovigilance in the product lifecycle...

EMA Updates Guidance on Clinical Data Publication Policy

The European Medicines Agency (EMA) on Wednesday released a revised version of its guidance on complying with its new policy on the publication of clinical data .   The scope of this guidance document relates to phase 1 of Policy 0070. Policy 0070 is composed of two...

Factsheet on new rules on medical devices

  EXISTING RULES Outdated rules – rules on medical devices date back to the 1990s and don't reflect the technological progress made since then Control of high-risk devices such as implants relies on national Notified Bodies – separate bodies risk inconsistency...

REACH 2018: Create your registration dossier

If you are registering a substance that other companies are also registering, you need to work together with them and prepare a joint registration. For a joint registration, two types of dossiers can be prepared: A lead registrant dossier, which includes the identity...

REPORT :Adaptive Pathways Workshop

Over the past few years, the adaptive pathways concept has generated considerable interest among key stakeholders. While some stakeholders have supported the concept because of its potential to improve access to new medicines, others have voiced concerns about its...

EMA pharmacovigilance system manual

The EMA pharmacovigilance system is described in this manual, which covers the EMA organisational structure, responsibilities, procedures, processes and resources, appropriate resource management, compliance management and record management. This manual does not cover...

ISO 13485 :2016 Versão para download

A norma ISO 13485 tem como objetivo  garantir o cumprimento dos requisitos legais, a gestão dos riscos e a manutenção dos processos de projecto, produção e distribuição de dispositivos  médicos. A Formiventos disponibiliza a nova versão para download : Medical devices...

EU Telematics Strategy and Implementation Roadmap 2015 – 2017

The purpose of this document is to outline the EU Telematics strategy and its implementation from 2015 to 2017. The document describes the vision and strategy, which will be delivered through a related set of programmes and projects, which, combined, will address the...

New rules for Novel Food

REGULATION (EU) 2015/2283 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 November 2015 .on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of...