Pharmaceutical Law & Administration - QP Module

York
Monday, 06 October 2014
Pharmaceutical Law & Administration - QP Module
Monday, 06 October 2014 08:30 -
Friday, 10 October 2014 17:00 (GMT)

York Marriott Hotel
HS,BIO,GM,PL,QP,SM,CR,Q1
+44 (0) 1904 701 000
Tadcaster Road
York
YO24 1QQ
United Kingdom

Map and Directions

        



Pharmaceutical law and administration is a key foundation knowledge requirement for all Qualified Persons (QPs). This is clearly spelled out in the relevant article of European Directives 2001/82/EC and 2001/83/EC and in the current Qualified Person Study Guide. The QP must ensure that the relevant laws are being complied with. Thus, a thorough understanding of the laws and legal processes, within Europe and beyond, is essential. This is equally true for other pharmaceutical technical managers.

This extremely popular QP training module is designed to ensure that, in an increasingly changing world, you have a deep and detailed understanding of…
  • Why we have medicines laws and what they seek to achieve
  • The laws and legislative processes within the EU which impact on medicinal products, and hence the role of the QP
  • The UK medicines legislative framework
  • US and other international pharmaceutical legislation
  • Other relevant laws and guidelines

Course Outline


European Medicines Legislation

  • The legislative framework in the EU
  • EU Directives affecting medicines
  • Organisation and function of EMA
  • Rules governing medicinal products in the EU (EudraLex)
  • Importation into the EU and distribution within the EU (wholesale dealing)
  • Powers of the licensing authorities and adverse licensing reports
  • Pharmacovigilance
UK Medicines Legislation
  • Background and development of UK medicines legislation
  • MHRA and VMD
Other Relevant Legislation
  • US legislation and FDA
  • International Conference on Harmonisation (ICH)
  • PIC/S
  • Medical Devices

Discussion and Working Groups


 A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.

Additionally, discussion periods, including a course trainer panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Course Tutors

  • Mr Peter Gough
  • Mrs Liz Allanson
  • Mr Darren Jones

Why This Training Will Benefit YOU

The Aspiring Qualified Person
  • This series of 12 modules held over a 21 month period has been carefully designed to meet the requirements for theoretical training detailed in the latest UK Qualified Person Study Guide and EC Directives 2001/82/EC and 2001/83/EC.
  • All our training courses provide practical, face-to-face tuition in sufficient depth to prepare you fully for the challenges that lie ahead.
  • Our training is generally considered as the best available and our QPs are held in high regard within the industry.
  • As well as being accepted in the UK, our training courses are well known and accepted by several other EU countries, including Ireland, The Netherlands, Austria, Hungary and Malta.
  • You are more likely to become a QP with us than with any other training provider!

The Pharmaceutical Technical Professional
  • Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers within other areas of pharmaceutical manufacture and control.
  • Increasingly, companies are using these modules as part of a modular technical and professional development plan for their staff.
  • Additionally, many industry professionals attend the courses as part of their Continuing Professional Development.
  • This course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications depending on modules taken and work commitment by students. For further details, please contact Stella Pearson-Smith, our QP Course Administrator at QPpharma@nsf.org for more information

The start and finish times given are approximate, please contact our office for further information.

 

Contact Details

Payment Instructions

  • Payment Methods

    By Bank Transfer — We are happy to accept payment directly into our bank account so long as:
    • the full amount of the invoice is received net of all local and UK bank charges within 30 days from date of invoice
    • the payment timescale quoted at the bottom of our invoices is strictly adhered to
    • a remittance slip giving clear details of our invoice number is received at this office to coincide with the payment being credited to our bank account

    Our bank details will be sent with the invoice.

    By Cheque — Payment should be made by sterling cheque drawn on a UK bank and payable to NSF Health Sciences Ltd. Please ensure that the full invoiced amount, net of all local and UK bank charges, is received within 30 days from date of invoice. 

    Please note that, in both cases, if any bank charges are deducted prior to receipt, this amount will be re-invoiced to yourselves.

    By Credit or Debit Card — Using Regonline Secure Payment facility.

    Payments — A VAT invoice (if applicable) will be provided (VAT Reg No. GB 927 3679 85). Settlement must be received at least 10 working days prior to the course start date. Cancellations within 25 working days of the course start date are subject to charges (see Cancellations section below). If a Purchase Order number is necessary to effect settlement of our invoice, please provide.

    Cancellations — Written cancellations with a full refund will be accepted up to 25 working days before the start date of the course. A fee of 50% will be payable for cancellations received between 10 and 25 working days before the start of the course. Full course fees will be charged for cancellations received within 10 working days of the course start date. Delegate substitutions may be made at any time up to the start of the course. Refunds will be made within 30 days of receiving the written cancellation by the same method that payment was made.

    Late Payment Clause

    We understand and will exercise our statutory right to claim interest at 2.5% above the prevailing Bank of England base rate under the Late Payment of Commercial Debts (Interest) Act 1998 if we are not paid according to our agreed credit terms.

    The programme and other information contained on this website are correct at the time of publishing and are published in good faith. We reserve the right to make any changes which may become necessary.


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