About this course
The manufacture and supply of IMPs presents many unique challenges and there are significant differences around how GMPs are interpreted through the different phases of clinical manufacture, when compared to commercial products.
Supply of IMPs can often be on the critical path; therefore, it is key that all staff involved have a clear understanding of the current regulatory and GMP/GCP expectations and industry practices.
In the US and EU the profile of investigational new drugs has increased significantly in recent years. In addition, clinical studies in the Asian region and key emerging markets have been of high interest to firms pursuing global product launch strategies or targeting disease states in particular regions of the world.
Well thought out clinical supply strategies often fail to take into account details of the EU Clinical Supply Directive 2001/20/EC and local Qualified Persons release requirements. Furthermore, emerging market requirements and packaging / shipping clinical supplies present very unique challenges.
How This Training will Benefit You
This course provides the tools and techniques required to make informed, science and risk based decisions to benefit both the business and the patient. The information you will gain will help you or your staff maintain uninterrupted supply of clinical materials.
It will provide the background and knowledge needed by every Quality Professional and Technical Leader whether in Production, Quality, R&D, Validation, Engineering, or any other technical discipline. As with all of NSF-DBA’s courses, it is led by industry and academic experts; frequently incorporating case studies and small group sessions to facilitate learning.
NSF-DBA’s format of extended days and pre-work ensures that both you and your company benefit from the learning experience in an efficient way and with minimal time away from the workplace.
This course on Investigational Medicinal Products is based upon a key component of the Qualified Persons instruction which NSF-DBA offers in Europe. A Certificate is granted by NSF-DBA for attendance. Higher degree options – a Diploma and a Masters in Pharmaceutical Quality and Good Manufacturing Practice from the University of Strathclyde can be obtained by attending a full series of courses.
Continuing Education Credit
- ACPE Continuing Education Units = 3
- Reference Activity Number = 0616-9999-11-006-L04-P
Course outline
This course is designed to provide the Quality Leader with the foundation knowledge and understanding required to assess and certify IMPs 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.
The Clinical Trial
- The phases of clinical trials
- Impact of trial design on manufacturing and packing operations
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
The Regulatory Framework
- FDA Regulations and Guidelines for IMPs
- Directives 2001/20/EC and 2005/28/EC
- EU GMP – Annex 13
- ROW considerations
The Role of the Quality Leader
- 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 EU
- Two stage release process
Good Clinical Practice
- What is GCP?
- The GMP/GCP interface
Venue
Boston Marriott Long Wharf Hotel, Boston, MA, USA
Located one block from the Financial District, Boston Marriott Long Wharf offers visitors fantastic views of the Boston Harbor with its waterfront setting.
Guestrooms are fitted with modern amenities such as Marriott’s signature Revive beddings, coffee maker, refrigerator and wireless Internet technology. Indoor pool, spa, sauna, health club provide indulgence and recreational options. The hotel specializes in sumptuous seafood dishes. Extensive meeting facilities cater to private events and conferences.
Boston Marriott Long Wharf is close to Quincy Market, Faneuil Hall, TD Banknorth Garden, Museum of Science and Boston Common.
Hotel Accommodation
NSF-DBA has negotiated a preferred rate with the Boston Marriott Long Wharf Hotel. A limited number of rooms are available at this rate. Hotel reservations and payment are the responsibility of each delegate.
We will be happy to help but final confirmation and bill settlement is the delegate’s responsibility.
Venue Address and Contact Details
Boston Marriott Long Wharf Hotel, Boston, MA, USA
296 State St,
Boston
Massachussets 02109, USA
Tel: +1-617-227-0800
Boston Marriott Long Wharf Hotel, Boston MA
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 Our QLP Courses
“Course was detailed and comprehensive. I was concerned that, due to the modular nature of these courses, I might be a little lost, but the course was presented well as an individual course. I liked the discussion and debate”
Andrea Murphy, Pfizer Biotech, USA
“Good course, will recommend to others in my current department: Clinical/R&D Quality Assurance.”
Robert Wherry, Sunovion Pharmaceuticals, USA
“One of the best modules I have attended!”
Zach Venyak, Medicis Pharmaceutical, USA
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