Basics of Pharmaceutical Regulatory Affairs

Basics of Pharmaceutical Regulatory Affairs
A highly-acclaimed one-day course which provides an awareness of the regulatory environment and an appreciation of some of the main regulatory processes and issues.

Who should attend

Regulatory Affairs can be a confusing and complex place particularly if you have no formal industry background. This course is ideal for:

  • Those new to regulatory affairs or those wishing to move into the profession
  • Experienced staff from related disciplines, e.g. manufacturing, marketing and sales
  • Support staff
  • Anyone requiring an overview of regulatory affairs

What previous delegates have had to say about this course…

“ Speakers very clear, concise and informative”     
    “ Excellent overview in such a short time!” 
 “ Well structured set of presentations and very informative.”    
     “ Made things a lot clearer and gave me an understanding of how things link together.”

What you will learn

  • Background to regulatory affairs
  • The European legislative framework
  • Overview of drug development
  • Overview of clinical trials
  • Marketing Authorisation Applications
  • Labels and leaflets
  • European Procedures
  • Lifecycle management, including variations

This course will give a basic grounding in a relaxed, enjoyable environment.

CPD

This course offers 5 CPD hours for successful completion

Why is Continuous Professional Development important?

As a professional in regulatory affairs you have a personal responsibility to maintain your level of knowledge and competence; you are therefore encouraged to participate in Continuous Professional Development.

CPD is important to you as; 

  • It demonstrates to your employer that you have planned, updated and maintained your knowledge and experience.
  • It enables you to develop your knowledge and experience for your present role and any potential future roles.



This course is now fully booked. Please email meetings@topra.org to be added to the waiting list.

 

Course prices (including VAT):
Registration Fee: £660 

Those working for regulatory agencies or government agencies or academic institutions: 
Registration Fee: £495 
For the 25% discount please contact meetings@topra.org for the code

Those working for charities, patient groups or in full time education: 
Registration Fee: £165. 
For the 75% discount please contact meetings@topra.org for the code

Please note the number of discounted places may be limited.
All fees are shown in Pounds Sterling and include VAT
 

- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable)
- All cancellations must be received in writing 28 calendar days before the start of the course and will be subject to an administration fee of £100 + GB VAT. We regret that registrations cannot be transferred to another course, however delegate substitutions may be made up to 10 working days before the course.


All fees are shown in Pounds Sterling and include VAT (where applicable)

 

If you work for an SME in England you may be eligible to receive funding of 50% of the total course fee from Cogent Skills as part of the UK government Science Industry Partnership (SIP). Please contact kate.griffiths@cogentskills.com for more information.

 

When
20/08/2015
Where
Basics of Pharmaceutical Regulatory Affairs TOPRA, 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
This event is full.
My registration status: Not registered
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Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

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