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!
Very Informative!
Thanks a lot.
Warm Regards,
Dr.S.R.Parakh.
Thank you.
I hope this series of training modules will meet a need from individuals looking personally to develop their own careers by improving their regulatory competences.
A lot of work has gone into preparing each module to ensure a high standard of regulatory content.
We have more new modules in the planning stage for later in 2012 but suggestions for additional regulatory science topics of interest will also be welcomed. I hope you and others will feel able to add your ideas.
Kind regards
Mike