GMP for Clinical Trials Manufacture and Supply
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The implementation of Directive 2001/20/EC has brought profound changes
Dates: Monday 10 to Thursday 13 June 2025
Venue:
Manchester Marriott Victoria and Albert Hotel, Manchester, UK
Cost:
£2400.00 excl. VAT – £2880.00 incl. VAT
Type: Pharmaceutical
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
Manchester Marriott Victoria and Albert Hotel, Manchester, UK
The Manchester Marriott Victoria & Albert Hotel stands on the banks of the River Irwell, near the city centre but convenient for Manchester Airport (19km), the city’s Piccadilly rail station (3km) and the UK’s motorway networks.
Recently lovingly restored, this Grade II listed building bears many modern features. The hotel has its own car park and a few minutes’ walk takes you to the city’s main shopping and eating district.
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 are provided under the ‘Hotel Bookings’ section at the bottom of this page.
- 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
Manchester Marriott Victoria & Albert Hotel
Water Street
Manchester
M3 4JQ
England
Tel: +44 (0) 161 832 1188
Fax: +44 (0) 161 834 2484
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
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
“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
