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Free Regulatory Affairs and Pharmacovigilance webinars in 2012

13/12/2011

Following the popularity and success of the free webinars introduced this year, Wainwright Associates is continuing to offer this in 2012. New topics include the changes in Pharmacovigilance leglislation, information on Pharmacovigilance Inspections and Orphan Medicinal Products.
The full list of webinars for the first half of 2012 is listed below, including information on how to register.
 
An Introduction to Scientific Advice in the EU: 

This webinar is designed to give companies an introduction to scientific advice from regulatory authorities on the development of medicines in the EU:
 Routes for advice
Common principles
Special Topics (e.g. Protocol Assistance and parallel advice with the US FDA)
Centralised vs national advice: a few considerations

Thursday 19 January 4pm UK time; To register, please click here.
Thursday 26 January 8.30am UK time; To register, please click here.

The European Mutual Recognition and Decentralised Procedures - Introduction and Comparison:

This webinar is designed to help companies gain a better understanding of Article 28.2 of Directive 2001/83.

The content of the course will include:
The Mutual Recognition Procedure – Introduction, scope and timetable 
Decentralised Procedure- Introduction, scope and timetable 
A comparison between Mutual Recognition and Decentralised procedures

Tuesday 14 February 4pm UK time; To register, please click here.
Thursday 21 February 8.30am UK time, To register, please click here.

Regulatory Authority Pharmacovigilance Inspections:

This webinar is designed to inform anyone who is involved in preparing for pharmacovigilance inspections:

How to prepare for the inspection
What to expect from an inspection- timescales, information etc
Conduct of the inspection
Post-inspection action
 
Thursday 15 March 4pm UK time; To register, please click here.
Tuesday 27 March 8.30am UK time; To register, please click here.

Orphan Medicinal Products in the EU:  Eligibility, Orphan Designation and Incentives

The structure of this webinar is:

Introduction:  Legislative Basis and Criteria for Eligibility
The Committee for Orphan Medicinal Products: Organisation and Role
Incentives
Applications for Designation
Annual Reports and Maintaining Orphan Designation

Tuesday 17 April 4pm UK time; To register, please click here
Thursday 26 April  8.30am UK time; To register, please click here

The Roles and Responsibilities of an EEA Qualified Person for Pharmacovigilance (QPPV)

This webinar is designed to help companies understand their responsibilities and duties towards a QPPV and how they can meet their obligations. The content of the course will include: 
Details of what is required from a QPPV
Responsibilities of the QPPV
Company’s responsibility towards the QPPV
 Local QPPVs
The practical aspects of QPPV

Tuesday 15 May 4pm UK time; To register, please click here
Thursday 24 May 8.30am UK time; To register, please click here

The new EU Pharmacovigilance legislation 

This webinar will offer companies:

A brief overview of the key changes
Information on the main implications of these changes to the industry

Tuesday 12 June 4pm UK time; To register, please click here
Thursday 21 June  8.30am UK time; To register, please click here