Tag Archives: PharmaQMtraining.eu

regulatory intelligence

Our Current Objectives

Good regulatory practice and individual professional codes require staff working in pharmaceutical regulatory affairs to be trained appropriately and to maintain their professional competences [Continuing Professional Development (CPD)].

Through our regulatory consultancy and training businesses Pharmaceutical Quality Matters and PharmaQMtraining.eu, we can provide regulatory expertise and training on pharmaceutical subjects concerning drug substances (active substances) from their discovery onwards until they become drug products (finished medicinal products/dosage forms). If an active substance is new the regulatory demands can be huge whereas if it is a known or ‘existing’ drug substance the regulatory burden will usually be much lighter unless a new method of administration or a novel formulation is involved.

Complex regulatory procedures have to be followed and satisfied before a clinical trial can begin and there are even more extensive requirements to be met in order to gain approval of an application for a Marketing Authorisation (MA) (also known as a Product Licence, particularly in the UK) to allow a specified product to be sold or supplied to patients.

In all cases the industrial Intention of medicines’ development is to produce a safe and effective product but the story does not end with the granting of a MA. Adverse events have to be monitored, this being part of the major effort put into the regulatory topic of Pharmacovigilance.

For each particular approved medicine there is also the need for life-cycle management to keep any given product up to the required quality, safety and efficacy standards whilst recognising that commercial considerations and maintenance of supply may also be key factors.

In this site’s Blog Posts and also through the LinkedIn group Pharmaceutical Regulatory Training we will try to focus our writings on regulatory intelligence impacting on medicines’ development with a focus on new legislation and new guidelines and other relevant guidance from ICH and various national/multinational bodies in order to see how and where these may have an impact on the licensing and life-cycle management of new medicines. Contributions and analytical comments from readers will be welcomed especially where they enhance the training potential offered by these activities.

Facebooktwittergoogle_plusredditpinterestlinkedinmail

A Unique Pharmaceutical Regulatory Training Resource

Announcing the latest online streaming video training modules for individual self-development programmes

A NEW WAY TO RECEIVE OUR TRAINING, STARTING NOW AND AT TIMES CONVENIENT TO YOU

The current collection of our e-Training Modules in the “HOW MEDICINAL PRODUCTS ARE LICENSED IN EUROPE” series is:

  • Training Module 1: Overview of the EU Regulatory System: Institutions, Agencies and other Involved Bodies
  • Training Module 2: Regulatory Overview of the Role of the European Pharmacopoeia
  • Training Module 3: On Pharmaceutical Licensing, its Legislation and Useful Guidelines
  • Training Module 4: An Introduction to the Legal Basis for a Marketing Authorisation
  • Training Module 5: Why …. and How to …. provide Drug Substance Data in support of a Marketing Authorisation Application

The selection list will grow and new additions are already in preparation.

More than 800 million Europeans live in about 50 countries in Europe. They have or strive for access to modern medicines.

For about 50 years there has been an evolution of pharmaceutical regulatory systems and industry practices aimed to deliver safe and effective drug products to prevent or treat ill-health.

The numerous national and multi-national official institutions and legal and procedural elements involved in this regulatory system are complicated to understand. The video training modules explain the complex frameworks within which global innovator and generic companies have to operate in the European Union and much more.

The European Pharmacopoeia has an inescapable influence on the Quality of human and animal medicines sold or supplied in the European Union (EU) and beyond. Much of its content is, in appropriate situations, mandatory and not just for guidance. Our e-Training helps people working in research, development, manufacturing, analytical, regulatory and other roles in the chemical, pharmaceutical and biopharmaceutical industries to know which pharmacopoeial requirements MUST be met and when!

The legal basis on which a Marketing Authorisation application may be submitted to and hopefully approved by the Licensing Authorities is another complicated area that is navigated with examples in the video training modules. It is important because it determines the nature and extent of the supporting information on pharmaceutical, non-clinical and clinical subjects that must be compiled in Common Technical Document or CTD.

The e-Training series offers regulatory insight drawn from the expertise of former EU regulators with enormous experience in different branches of the pharmaceutical industry and deals with legislation, official and other guidelines, procedures, policies and practices of relevance to gaining and maintaining Clinical Trial and Marketing Authorisation approvals. The training is delivered with care, clarity and expertise and each online module ends with an on-screen written reprise to help reinforce the learning process.

Choose a presentation that interests you. Pay only a fraction of the cost of attending a Course in person. Pay by credit card or PayPal. For a single payment watch a presentation on several occasions within a defined period, stopping and re-starting it as you wish.

This should be an easier way of learning and we certainly try to make it so!

Facebooktwittergoogle_plusredditpinterestlinkedinmail