In collaboration with the Medicines and Healthcare products Regulatory Agency we are holding a two day training session for clinical pharmacologists.
Day one
10-11am: Registration and refreshments
11am: Welcome
11.05am: Introduction: Overview of the work of MHRA
11.35am: Clinial trials applications, Dr Kirsty Wydenbach
12.05pm: Jenny Martin
12.35pm: Non-clinical information for clinical trials and marketing authorisation application, David Jones
1.05pm: lunch
2pm: CTA workshop, Dr Kirsty Wydenbach
2.45pm: Feedbac from workshop
3pm: Discussion and Q&A in clinical trials
3.10pm: Coffee break
3.30pm: Licensing of medicines – an overview, Sui Ping Lam, Director of Licensing Division, MHRA
4pm: Quality matters, Sue Harris
4.30pm: Establishing efficacy - Statistical considerations in clinical trial design, Dr Khadija Rantell
5pm: Benefit: risk assessment – data to support a marketing authorisation application, clinical aspects of the assessment of efficacy and safety, Dr Dan O’Connor
5.30pm: Discussion and Q&A in licensing medicines
Day two
8.45am-9.15am: Registration
9.15am: Medicines for paediatric patients, Dr Eleni Gaki
9.40am: Workshop on topics related to new medicines
10.25am: Feedback from workshop
10.40am: Coffee break
11am: Monitoring safety of medicines: why, who and how, Dr June Raine, Director of VRMM Division, MHRA
11.15am: Triggers for safety concerns, Helena Bird
11.30am: Analysing safety data and investigating signals, Stephanie Dellicour
11.50am: Bringing the data together: managing risk; EU co-ordination, Dr June Raine, Director of VRMM Division, MHRA
12.10pm: Communicating changes in benefit and risk balance, Dr Julie Williams
12.50pm: Discussion and Q&A in licensing medicines
1pm: Lunch
2pm: Workshop on new safety information
2.30pm: Feedback from workshop
2.45pm: Herbal Medicines: What do clinical pharmacologists need to know about herbal medicines, Sue Harris
3.15pm: Devices: key issues and future strategies
3.45pm: closing remarks, Professor Sir Michael Rawlins, Chair MHRA
Register your place now by emailing
Lisa Hevey.