PPTA Europe’s Post

Today I have the honour to present our poster ‘NITAGs are essential for succesful implementation of the EU Regulation on HTA’ at the HTAi, where we discuss recommendations for involving NITAGs in the EU HTA regulation. If you are interested, our poster is displayed at poster board 14. I will also provide a brief overview during presentation session 20, "Global HTA and Regulations: Bridging Policy and Practice."

Science is organized knowledge that the public should have access to. Afterall, informed choices can only be made if accurate information is available. Here, we mean tobacco harm reduction specifically. We make our research publicly available 👉 http://spr.ly/6045iqYx3 #HarmReduction #TobaccoHarmReduction #PublicInformation #OrganizedKnowledge #OpenAccess

The UK Regulators' Network has just published our recent response to the Department for Business and Trade's call for evidence on Smarter Regulation and the Regulatory Landscape. Our response includes our commitment to continual improvement and also sets out some of the great work our members already do as well as some key areas for further development. Use the link in the below to read the full response. #UKRN #callforevidence #network #regulation #regulators #smarterregulation

Updating the annexes to the EU Dual-Use Regulation Updating Annex I to Regulation (EU) No. 2021/821 (EU Dual-Use Regulation) With the delegated regulation of September 5, 2024, the EU Commission has initiated the updating of Annex I to Regulation (EU) No. 2021/821 (EU Dual-Use Regulation). This delegated regulation is expected to come into force in November 2024.

Sharing Riks panel discussion about the security and public health risks connected to the rise in illicit products’ consumption across the EU. Some MEPs speaking with Riks encourage the Commission to learn more about the countries that are beating illicit products’ trade while managing to reduce connected public health burdens, before considering additional regulation and taxes.

On 17 July 2024, the new Regulation on standards of quality and safety for substances of human origin intended for human application has been published. Discover the key changes and implications for our field. Click the link to read more👇🏻 #safety #quality https://lnkd.in/dfet8FfZ

The research is clear. The current psych*d*lics field perpetuates the harms done by the War on Drugs and something needs to change. Check out what our founder had to say about it during a recent presentation at Harvard Law's Petrie-Flom Center 2024 Annual Conference. Curious to learn more about this and other plant medicine topics? Head on over to our website! www.pocpc.org

Life constantly evolves, and staying connected and informed is essential to effectively serve diverse communities by embracing traditional practices, ancestral wisdom, and current knowledge. Lately, I have been learning about the development of an ethics and policy framework for Psychedelic Clinical Care, an area that is gaining precedence. In March 2023, after completing a comprehensive childbirth training program, I gained valuable insights into both Western medicinal practices and the herbal medicinal traditions of Costa Rica. This experience deepened my understanding of traditional medicine and other ancestral practices. I acquired valuable knowledge about plant medicine and its diverse healing applications through careful observation. Additionally, hearing the stories of individuals who experienced these practices further piqued my interest. Before this training, my knowledge of psychoactive medicine was limited to traditional teachings from my community. However, delving into its various aspects and contemporary approaches quickly became my primary interest. The use of psychedelic therapies as alternative treatments is gaining traction in Western medical practices. Despite historical restrictions on psychedelics, there is a growing scientific and public interest in these substances. Numerous clinical trials have showcased their potential in treating mood, anxiety, and substance use disorders. The projected growth of the U.S. market for psychedelics, reaching $6.85 billion by 2027, has attracted a significant number of for-profit companies and investors due to their therapeutic and commercial potential (POPLAR). The potential for advancements in psychoactive treatment to offer remedies for individuals warrants careful consideration. As we delve further into Psychedelic Clinical Care, it is crucial to evaluate the implications thoroughly, reflect on the journey that has led us to this juncture, and contemplate the appropriate course of action, all while upholding respect for the traditional and cultural practice of medicine. Innovative practices often stir up anticipation and interest among professionals in various fields. It's an exciting time to assist clients in numerous capacities 😊, but with the potential for misappropriation and misuse of sacred practices.

GRADUAL ROLL-OUT OF EUDAMED!!! The EU Parliament just voted the amendment for a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices with 511 out of 533 favorable votes. Next step will now be European Council approval, though the Council already indicated they will approve this amendment. Publication in the Official Journal of the EU is expected next month. Link to the final text: https://lnkd.in/dDJDM7ve The EP session can be followed at the following link: hhttps://lnkd.in/dZUy_FYR Voting for this amendment is at 12h18

Great news from the European Parliament with a positive vote in favour of the amendment of #IVDR and partially #MDR through the gradual roll-out of Eudamed. Thank you for sharing Stefano Bolletta. Pending European Council approval but at formality at this stage, it will be great to see this published in the OJEU next month. Hopefully, this amendment will help alleviate supply shortages with an obligation for manufacturers of medical devices and IVDs to inform their Competent Authority and Health Institutions before they temporarily or permanently cease the supply of a critical device. Further information via link to final text below. #medicaldevices #invitrodiagnostics #regulations