About this course
The Responsible Pharmacist and Quality Leadership Program (RPQL) is a collection of 10 specialized modules aimed at equipping and empowering these important decision makers in South Africa. It is delivered by world leading experts from NSF-DBA, based in the US, UK and South Africa, in collaboration with leading professionals from the School of Health Sciences at the University of KwaZulu-Natal.
The adoption in the EU of Council Directive 2001/20/EC means that:
- All clinical trial materials must be made in accordance with the principles of GMP
- Manufacturing facilities must hold an appropriate authorization and will be subject to inspection by the regulatory authorities
- All investigational medicinal products must be subject to certification by a Qualified Person prior to release into a trial
This course is designed to provide clinical and other professional persons involved in clinical trial design and monitoring, also Responsible Pharmacists, how to assess and certify investigational medicinal products and to appreciate the fundamental differences between IMPs and licensed products. It will also be of value for other technical staff working with clinical trial supplies.
Course outline
The Clinical Trial
- The phases of clinical trials
- Impact of trial design on manufacturing and packing operations
Regulatory Framework
- PIC/S Guidelines for Clinical trials
- EU Directives 2001/20/EC and 2005/28/EC
- Annex 13
Role of the Responsible Pharmacist or Quality Professional
- The legal duties
- Key documentation – the CTA, the IMP dossier and the Product Specification File
- Control and certification of products manufactured or sourced outside the European Union
- The two stage release process
- The role of the EU QP in split manufacture and in virtual companies
- The special challenges
Good Manufacturing Practice
- Sourcing of materials, including comparators
- Production and quality control of IMPs
- Packaging issues – blinding and product security
- Validation – how much, how soon?
- Assigning and extending shelf life
- Retains and returns
- Assessing ‘equivalence’ of GMP standards
Good Clinical Practice
- What is GCP?
- The GMP/GCP interface – when do the responsibilities of the QP end?
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, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Venue
Glen Hove Conferencing, Johannesburg, South Africa
Glen Hove Conferencing is centrally located in Johannesburg and close to the very popular Melrose Arch Complex with its superior hotels and dining facilities. Glen Hove Conferencing is the headquarters of the Southern Gauteng branch of the South African Pharmaceutical Society.
For assistance in finding accommodation please contact the Course Convener, Dr A J Thomas on [email protected]
The courses will be held in the ultra modern Upper Glen Hove meeting room which can comfortably seat 80 persons. Acoustics in the room are excellent as is the standard of catering facilities provided. For further information please visit the conference centre’s own website at www.glenhove.co.za or email them at [email protected]
Catering
During the course, mid-morning tea plus snacks will be served at approximately 10.00 with afternoon tea served at 15.00. At lunchtime you can enjoy an appetising finger buffet served in the foyer.
After each day’s activities a closed bar service will be available, chargeable to your account where relevant.
Special Dietary Requirements
If you have any special dietary requirements, please contact the conference management.
Venue Address and Contact Details
Glen Hove Conferencing, 52 Glenhove Road
Melrose Estate, Johannesburg, 2196
PO Box 2467, Houghton, 2041
Tel: 011 442-3601
Fax: 011 442-3678
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
What you've said
What Previous Attendees Said About This Course in Europe
“It was the best course I have ever done. Great.”
Sonja Glanzmann, Merck, Switzerland
“Buzz groups very useful – specifically the ‘tic-tac’ one. Good interactive course and tutors/guest speakers – good to see their news and implementation of regs and problems encountered at their sites.”
Donna Stewart, Almac Group, UK
“Excellent outline and breakdown of issues facing IMP QPs, will be of real value going forward.”
Bertie Craig, Newcastle University, UK
“I found the delivery by the tutors, the knowledge of the guest speakers and the course materials to be of a very high standard.”
Ming Ng, Forest Laboratories, Republic of Ireland
“Very useful course. A whole new world has been opened. It also changed a wrong perception that IMPs follow lower GMP and are less complex. Thank you.”
Nuno Furtado, Baxter Healthcare, UK
“Good mix of lectures and team activities.”
Marcel Birri, Roche Products, Australia
“Very good introduction to IMPs.”
David Bell, Reckitt Benckiser, UK
“Very good content. Lots of information about IMPs and gained significant knowledge.”
Mohammad Arselaan Khan, Accord Healthcare, UK
“Quality and content pitched at the right level.”
Matt Dodd, Catalent Pharma Solutions, UK
“Well balanced stuff, excellent tutors. Loved the tic-tac exercise.”
Sandor Vig, GlaxoSmithKline Biologicals, Hungary
“Excellent as ever. Very useful – learnt lots. Very social good discussions.”
Seb Hodgkin, Barts Health NHS Trust, UK
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