Trainings from net zealous llc on new eu pharmacovigilance directive and regulation

1. Netzealous LLC
Trainings from NetZealous LLC on New EU
Pharmacovigilance Directive and
Regulation

2. • NetZealous LLC offers professional trainings on the New EU
Pharmacovigilance Directive and Regulation.
• Fremont, CA, July 14, 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.

3. 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.

4. Replaces
Existing
Guidelines

5. 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.

6. Professional trainings that cover all
aspects of EU Pharmacovigilance
• Professional trainings from NetZealous LLC offer guidelines on this
legislation by covering these aspects:
• Complete overview of the EU Regulatory structure
• Why were these changes made into EU Pharmacovigilance now?
• The way in which PV Modules are organized
• Ways in which the new EU Pharmacovigilance legislation will
improve and protect patient safety and affect Marketing
Authorization Holders and Sponsors of Clinical Studies
• Post-Authorization Safety Studies
• Eudravigilance Database
• Changes to labeling
• The Pharmacovigilance Risk Assessment Committee
• Implementation timing & expectations

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