Thursday 5th December 2024
Regulatory Hot Topics IX
Royal Society of Chemistry, London
The topic of mitigating counterfeit and falsified medicines will open the JPAG Hot Topics meeting this year. Falsified medicines are fakes that are designed to mimic real medicines whereas Counterfeits are those that do not comply with intellectual-property rights or that infringe trademark law. Both may impose a serious public health threat globally on consumers and patients. According to WHO in 2018, counterfeit medicines represented 10% of medicines globally and result in death of around 1 million individuals annually. Until recently, those most frequently found in wealthy countries were expensive 'lifestyle' medicines such as hormones, steroids and antihistamines and in developing countries, medicines used to treat life-threatening conditions such as malaria, tuberculosis and HIV/ AIDS. The phenomenon is on the increase with more and more medicines now being falsified including expensive medicines (such as anticancer medicines) and medicines in high demand (such as antivirals). This symposium introduces the topic and highlights some key themes and case studies from both an industry and regulatory perspective. This could include:
- Systematic approaches to measuring the scale of the problem
- Mitigating and fighting the spread of counterfeits
- Illegal online pharmacies and dark web
- Innovation in blockchain and the role it plays in supply chain
- Smart packaging and labelling
- Efficiency of track and trace technology in preventing the spread of counterfeits
- Increasing public awareness towards harm resulting from counterfeit medicines
- Analytical approaches to detecting counterfeit medicines
- Different approach to assessing medicines quality
- Detection of counterfeit medicines outside the lab

Other topics for the meeting include updates from the British Pharmacopoiea (BP) team and some highlights on ePILs and devices. In addition, speakers will share their recent experiences and updates on the ongoing nitrosamines and titanium dioxide activities with hopes for the future. The programme will also look at the revision of ICH Q6A.

The meeting is open to the submission of abstracts for posters in line with the above proposed key themes. We would especially welcome case studies on any pharmaceutical counterfeit work across industry and academia.

In addition, there is an evening in-person opportunity (5-7pm) to meet other regulatory professionals over drinks and canapes in this fabulous central London setting with both JPAG and TOPRA members. Don't miss this festive opportunity to meet like-minded, charming and inquisitive regulatory professionals and find out what other people are working on and the latest regulatory hot topics. There are 40 spaces available to attend on a first come first served basis, so please consider booking into the meeting (by e-mailing events@jpag.org) well in advance to secure your evening of merriment and networking.

Speakers:
Dr Andrew Teasdale - AstraZeneca
Dr Neville Broad - Viatris
Gabriela Fok - Ipsen
Kevin Hughes - Colorcon
Dr Janine Jamieson - IPQ
Adam McCudden - AstraZeneca
Andy Morling - Deputy Director (Criminal Enforcement), Criminal Enforcement Unit, MHRA
Dr Bassel Odeh - Medicines and Healthcare products Regulatory Agency
Stephen Young - MHRA