About this course
The implementation of Directive 2001/20/EC has brought profound changes to the way clinical trials are conducted in the EU and equally important changes to the way IMPs are manufactured and controlled.
Few people within the pharmaceutical and healthcare sectors would question the wisdom of greater uniformity of approach to the conduct of clinical trials in Europe, but the application of the Directive is proving to be a significant challenge to manufacturers of clinical supplies…
- What ‘standard’ of GMP is appropriate at the various clinical trial phases?
- Validation – how much, how soon?
- What exactly is a Product Specification File?
- In the case of split manufacture, whose QP should release?
- What is the role of the QP when IMPs are imported?
- Where does GMP end and GCP begin?
- How do QPs deal with comparators?
All of these questions and many more will be addressed in this intensive four-day training course.
What You Will Learn
- Current EU and US GMP regulations and expectations for the manufacture of IMPs
- How to apply these GMP expectations in a scientifically sound and cost-effective manner in the best interests of…
- your company
- the clinical trial volunteer
- The role of the QP in clinical supplies manufacture
Course outline
The Clinical Trial
- Phases of clinical trials
- Impact of trial design on manufacture and packing
EU Legislation
- 2001/20/EC, 2003/94/EC and 2005/28/EC
and their implications for manufacturing, labelling, packaging, control and release of IMPs
Annex 13
EU and FDA Expectations Compared
GMP Issues for Premises
- What the guidelines say
- Equipment qualification
- Cleaning
Control of Starting Materials
- Specifications
- GMP for storage areas
- Sampling plans
- Release procedures
GMP Issues for Active Ingredient Manufacture
- Applying ICH Q7/Part 2
- Challenges of scale-up
Manufacture of the Dosage Form
Labelling and Packing Issues
- Control of packaging components
- Control of label printing
- Strategies to avoid mix-ups
- Blinding issues
- Stability testing/expiration dating
Validation Issues
- How much, how soon
- Cleaning validation or verification
- Analytical method validation
Documentation Issues
- IMP dossier
- Product Specification File
Release Procedures and the Role of the QP
- Two-stage release process
- Role of the QP
- Split manufacture and virtual companies – who is responsible
Change Control
The GMP/GCP Interface
- Relabelling
- Site-to-site transfers
- Complaints and recalls
Shipment of Clinical Supplies
- Storage
- Distribution
- Cold chain supplies
Discussion and Working Groups
A significant proportion of the course will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods including a tutor-led panel session will provide delegates with an opportunity to have their specific questions answered.
Venue
Park Hotel Amsterdam, Amsterdam, The Netherlands
At the hub of Amsterdam’s best city centre location, Park Hotel Amsterdam combines stylish looks and cosseting service with a contemporary mindset.
The combination of location, considered design, sophisticated luxury and hi-tech offerings make Park Hotel Amsterdam the city’s premier hotel.
Hotel Accommodation
- Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which will be provided to you on receipt of a completed booking form.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Venue Address and Contact Details
Park Hotel Amsterdam
Stadhouderskade 25
Amsterdam, 1071 ZD
The Netherlands
Tel: +31 20 671 1222
www.parkhotel.nl
Hotel Bookings
To make a hotel reservation at the Park Hotel please complete the Reservation Form that will be attached to the confirmation letter we will send you and forward directly to the Park Hotel. Please ensure you are aware of the hotel’s cancellation policy as NSF-DBA are not responsible for any charges in connection with your hotel reservation.
Hotel Bookings
If you would like to benefit from our specially negotiated bed and breakfast rate with the hotel, please book your accommodation following “this link”: Link to be confirmed at a later date
This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
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
“Very fruitful course, I learnt a lot about all GMP aspects throughout the manufacture of a clinical batch.”
Giovanna Marzano, Novartis Consumer Health, Switzerland
“An excellent course, especially the team works which forced me to think!”
Lena Ojstedt, McNeil, Sweden
“Team work sessions and tic tac exercise provided very nice and useful discussions.”
Niels Baron, Crucell Holland, The Netherlands
“Very nice course at the right level. Very interactive.”
Marije Liscaljet, Crucell Holland, The Netherlands
“This is a valuable course that covers GMP in every aspect of CT. This will certainly add value to my new role in QA and my company.”
Ruel Ferdinand, Brecon Pharmaceuticals Ltd, UK
“The lecturer and guest speakers presentations were really interesting and full of information that I can take back with me to my company and improve it (especially the QMS!).”
Veronique Maurer, Actelion Pharmaceuticals Ltd, Switzerland
“I found the course really valuable at setting the scene and covering the current issues relevant to GMP for IMP manufacture and supply. The opportunity to discuss in open forums common areas of interest and experiences between delegates and guest speakers was most helpful!”
Peter Jones, Oxford Biomedica, UK
“Has helped me to gain a picture and better understanding about GMP in CT.”
Nicola Grant, Biotech Services International Ltd, UK
“Very high quality course, completely in line with my needs as someone relatively new to the clinical trial materials arena.”
Mike Gerdes, Novartis Consumer Health, USA
“The course has given me an awful lot of food for thought and a long list of questions to take back home. Having no previous background, it gave me a very useful overview, with heavy emphasis throughout on the role of QP. Enjoyed validation and cleaning modules, could relate to these directly.”
Shelley Clark-Jones, BTG International Ltd, UK
“The TIC TAC exercise was excellent to show how complex packaging of clinical trials is.”
Charlotte Ullits Houlbjerg, H Lundbeck A/S, Denmark
An NSF International Company 
