Training Courses

The aim of the course is to provide attendees with a good basis to work from when involved in taking development candidates to the first in human trials with a view also on some longer-term requirements. The course content will therefore focus on the necessary early phases of chemical development as would typically be required to support production of up to about 2kg using laboratory-based 20L glassware.

Course Content

The course will introduce and discuss the following:

• Requirements in order to move from small (<1g) supplies to the first 100g or so for preclinical work 
• Further scaling to 1-2kg non-cGMP
• Requirements to make material for use in clinical trial – an introduction to cGMP coupled with the scaling issues
• An overview of the requirements to move processes to fixed vessels, assuming cGMP is required
• The phases of development and indicative timelines with quality requirements
• The importance of physical form selection, understanding and control

During the course, the lessons and the key learning opportunities are considered to be:

• How long does it take to get from milligrams to 1-2kg suitable for human clinical trials?
• What are the main hurdles?
• What can be left out and what must be included?
• What are the key project management considerations?

Case studies and problem sessions will also be included throughout the course.

But don't just take our word for it!  Here is what previous attendees have said about the course:

"I think the course was excellent for my current work as a chemist / project manager, because it touches on relevant process scale-up issues without expecting you to become an expert in any one thing."   Pfizer

"Very interesting course. I will recommend it to my colleagues."   Chiesi Farmaceutica SpA

"I'll recommend this course to my process development colleagues. It can help them to identify issues we are fcing at kilogram scale."   Schering-Plough

Who Should Attend?

• Project managers and those involved in technical outsourcing
• Project leaders and bench chemists involved in preparation of material
• New starters to the area
• Medicinal Chemistry support teams involved in making the first batches for toxicological evaluation