Trainings from NetZealous LLC on New EU Pharmacovigilance Directive and Regulation
Fremont, CA, August 12, 2016: NetZealous LLC, a provider of professional trainings in the areas of regulatory compliance, human resources, healthcare and IT, offers trainings from experts on the new EU Pharmacovigilance Directive and Regulation, whic
Fremont, CA, August 12, 2016: NetZealous LLC, a provider of professional trainings in the areas of regulatory compliance, human resources, healthcare and IT, offers trainings from experts on the new EU Pharmacovigilance Directive and Regulation, which came into effect in July 2012.
The European Union (EU) issued a new EU Pharmacovigilance Directive and Regulation which goes by the name Regulation No 1235/2010 and Directive 2010/84/EU. This legislation seeks to strengthen the pharmacovigilance requirements that existed earlier, and is essentially aimed at improving patient safety, as well as the process and outcomes of clinical trials, by introducing a pan-European system.
At its core, Regulation No 1235/2010 and Directive 2010/84/EU make reporting of the side effects of drugs easier and bring mechanisms for medicines that require extra monitoring. The legislation also seeks to put in measures aimed at educating the public better about the repercussions and outcomes of medication.
Replaces existing guidelines
The EU set July 2012 as the date from which the changes it brought into Regulation No. 1235/2010 and Directive 2010/84/EU will be implemented. Covering the major area of Good Pharmacovigilance Practices (GVP); what is novel about this new series is that it replaces the current set of Volume 9A of the Rules Governing Medicinal Products in the EU. In addition, Regulation No 1235/2010 and Directive 2010/84/EU also carry out an update into the legal structure and framework for pharmacovigilance on Medicinal Products for Human Use.
Regulation No 1235/2010 and Directive 2010/84/EU have from this date become the guideline on GVP in the whole of EU. Given the newness of this legislation, it is necessary for professionals who work in the area of EU pharmacovigilance to get trained on the use and ways of applying this legislation.
Familiarization with all the modules
These changes have been set out in the seven modules, which have been made available to the public for consultation. NetZealous LLC, in a series of trainings through one of its popular brands, Compliance4All, will offer participants an in-depth understanding of not only this, but also of related areas, such as other updates to the EU regulation and Directive.
Professional trainings from NetZealous LLC simplify the ways of understanding and implementing the new requirements. They also offer to participants all the latest information on related legislations, which is very important for regulatory professionals in the field of pharmacovigilance who they want to market their life sciences products to the very large and attractive EU market which consists of over half a billion people.
Professional trainings that cover all aspects of EU Pharmacovigilance
Professional trainings from NetZealous LLC offer guidelines on this legislation by covering these aspects:
o Complete overview of the EU Regulatory structure
o Why were these changes made into EU Pharmacovigilance now?
o The way in which PV Modules are organized
o Ways in which the new EU Pharmacovigilance legislation will improve and protect patient safety and affect Marketing Authorization Holders and Sponsors of Clinical Studies
o Post-Authorization Safety Studies
- Eudravigilance Database
- Changes to labeling
- The Pharmacovigilance Risk Assessment Committee
- Implementation timing & expectations
Regulatory Compliance Human Resources Healthcare IT
Aug 11, 2016