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Thursday 5th December 2024
Regulatory Hot Topics IX
Royal Society of Chemistry, London

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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 well in advance to secure your evening of merriment and networking.

Speakers:
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
Dr Andrew Teasdale - AstraZeneca
Stephen Young - MHRA


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There will be an opportunity to present posters on the broad subject area of the symposium, subject to acceptance of a submitted abstract.
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Delegate fees include registration, documentation, lunch and refreshments.


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DELEGATE RATES:
Concession : £ 45.00
Exhibitor SILVER : £ 850.00
Exhibitor-BRONZE : £ 700.00
Member : £ 195.00
Non-Member : £ 295.00
Student : £ 45.00


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SUBJECT: JPAG Symposium: Regulatory Hot Topics IX / Thursday 5th December 2024 / Royal Society of Chemistry, London

TITLE OF EVENT: Regulatory Hot Topics IX

DATE OF EVENT: Thursday 5th December 2024

EVENT LINK: https://www.jpag.org/175

VENUE: Royal Society of Chemistry, London
Burlington House, Piccadilly, London W1J 0BA

VENUE LINK: www.rsc.org/locations-contacts/

ORGANISED BY: Joint Pharmaceutical Analysis Group

WEB LINK: https://www.jpag.org/

SPONSORS: Royal Pharmaceutical Society and Royal Society of Chemistry

CONTACT: Hon Events Secretary JPAG, events@jpag.org


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 well in advance to secure your evening of merriment and networking.

SPEAKERS:
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
Dr Andrew Teasdale - AstraZeneca
Stephen Young - MHRA




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A recent analysis of the results has shown that more than 95% of attendees thought that JPAG meetings were well planned, relevant and met their main objectives, and would recommend JPAG meetings to colleagues


TESTIMONIALS...

Very enjoyable and thought-provoking day; going away with plenty of notes and specific items for discussion.

Excellent meeting, challenging and thought provoking. The organisation was excellent, thanks to all the efforts that JPAG team have made.

I have not attended a bad JPAG meeting yet. They are really good value for money and I really love to get the presentations as PDFs


I did appreciate receiving the slides before, as then I could print them and make notes around them during the symposium.

Getting an industry perspective on this topic was most helpful.

I appreciate having access to relevant JPAG seminars from overseas; provision of lectures beforehand to allow reading beforehand.

I did like having the presentations available early, with the webinar portion being focused on Q&A.

Fantastic to hear from NHS speaker, provides real insight to patient/clinician considerations that we don't necessarily see in industry.

From attendee perspective, the course did not take up the whole day as no travel necessary and overall good value for money.

Hearing the information from the clinical setting side was very useful.

Well organized. This was an amazing session. Prior sharing of the presentation was a great add on!

The most useful aspect of the webinar was the variety in the presentations across industry and the regulators. Really good to review the presentations beforehand.

Good value, well organised symposium. Always useful for focused topics.

A very good day. Enjoyed getting to speak to the presenters to discuss current challenges in industry.

Well done to all the speakers and the organisers for being able to successfully hold highly informative conferences virtually! (July 2020)



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