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Advanced European Regulatory Affairs

Course Objectives

The regulatory affairs market has always been of a fluid nature due to the constant changes in European regulations. Regulatory adherence is imperative for obtaining and maintaining marketing authorisation.

The knowledge gained from this advance regulatory affairs course is essential for continued success of pharmaceutical and related industries within the European Union.

Throughout the advanced regulatory training course delegates will examines current European legislation and the consequences of the changes for your Regulatory Affairs Manager. It also takes a look at and compares regulatory requirements between Europe and the rest of the world.

The course will empower you with the tools required to successfully navigate the minefield which is European regulatory affairs.

This course will ensure that delegates are completely up to date with the latest in legislation. This advanced course equips the participants with the knowledge and confidence to instigate the optimisation of the in-house regulatory procedures.

 

What Will You Learn?

  • Gain advanced tools necessary to optimise and maintain your regulatory procedures  
  • Obtain the knowledge necessary to keep up to date with new legislation in a constantly changing environment  
  • Facilitate improvement in your review and maintenance procedures
  • Improve your day to day management of regulatory affairs
  • Identify common problems and solutions through open discussions with regulatory experts
  • Learn to traverse the minefield of European regulatory affairs

Why you should attend this course?

  • All PTI programs are developed following extensive research with the industry, to ensure that the objectives of each course match your objectives.
  • Focusing on your business issues during our research ensures that each and every course can help you deliver immediate result when you are back in your office.
  • Application and implementation of industry knowledge and experience is the driver for our course design. Not theoretical, academic lectures.
  • Featuring a blend of interactive learning tools, including case studies, group discussions, scenarios, simulations, practical exercises and knowledge assessments; PTI courses focus on practical techniques.

NEW FOR 2012- Optional 1 Day Project Management Workshop

NEW FOR 2012- Optional 1 Day Project Management Workshop

25th June 2012 & 22nd October 2012

For those attending this two-day course there is also the option of attending an additional interactive workshop:

Project management soft skills:

Gain critical knowledge on factors which will contribute to successful projects and what you need to avoid.

The workshop will cover:

  • Leadership, Motivation and Stakeholder Engagement
  • Stakeholder Analysis and Management
  • Negotiation skills
  • Conflict resolution
  • Communication

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Dates and Venues

26 Jun 2012 - 28 Jun 2012

MWB Victoria

23 Oct 2012 - 25 Oct 2012

MWB Victoria

Reviews

"this course clearly helped me to come up to speed quickly. Most- if not all of the most important topics have been touched upon... a huge amount of information provided between the lines, especially on strategic level"
Novartis, DRA Manager
"Really good overall insight. Real life experience."
Regulatory Affairs Manager
JGL
"it will be very useful in my day to day job"
GSK, Registration Officer
"useful course- met my expectations"
2009 Delegate
"Very good and inspiring course"
RA Manager
Fresenius Kabi AB

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Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interactive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals 

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(updated 21 May 2012)


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