Traditional herbal medicines masterclass: Practical advice on registering a traditional herbal medicinal product (THMP)

09.00 Registration and coffee
09.30 Welcome and introduction by the Chair
Peter Bradley, BHMA
• BHMA
• BHMA and ESCOP Publications
09.45 Why register a product as a traditional herbal medicine
Elizabeth Williamson, University of Reading
• Alternatives for registration (THM, WEU, full MA or food/supplement/cosmetic)
• Benefits and disadvantages of registration
10.20 Practicalities of planning a submission
Thomas Brendler, PlantaPhile Ltd.
• Compiling a registration documentation - the basics and the process
• Key requirements (proof of tradition, quality, safety, claims)
• CTD
• Resources required and potential costs
11.05 Coffee
11.30 Compiling a Module 3 (chemistry and manufacturing)
Stefan Spiess, Gruenwalder GmbH
• GAP & GMP issues
• Herbal substance(s) / compound(s) / herbal product
• Analytical/pharmaceutical development (methods and validation)
• Manufacturing
• Stability
12.10 Compiling a Module 1 (product information)
Ann Godsell, Ann Godsell Regulatory
• Summary of product characteristics
• EMEA monographs and community list
• Labeling, package inserts and readability testing
• Pharmocovigilance system
12.50 MHRA experiences with assessment of THR applications
Linda Anderson, Medicines and Healthcare products Regulatory Agency (MHRA)
• Product information
• Chemistry and manufacturing
• Safety and traditional use
13.30 Lunch
14.30 Parallel rotating workshop sessions
Interactive workshops designed to give delegates the opportunity to interact with speakers and
resource persons in smaller masterclasses. Case studies on practical issues will be used to stimulate
discussion and delegates will be able to raise specific questions in a less formal setting. Three parallel
sessions will be run twice during the afternoon. Delegates can choose any two masterclasses and
are encouraged to submit questions in advance to be answered in the relevant class.
Workshop 1: Traditional use and safety
Workshop 2: Quality and stability
Workshop 3: Claims and labeling
16.00 Workshop feedback and closing remarks
All speakers and resource persons
16.15 Close

REGISTER BY FRIDAY 4 SEPTEMBER 2009 AND SAVE UP TO 15% (EARLY BIRD FEE)

NON-MEMBER   Early bird £325  Full fee £375
MEMBER OF RPSGB OR BHMA  Early bird £225  Full fee ££275