European Medicines Agency’s Post

Straight from horses mouths, link below for the hearing.

Gain firsthand experience from Parexel 's regulatory experts who have made over 250 EU-CTR applications, including almost 50 transition submissions. 📋 Our EU-CTR readiness can support you in navigating the requirements of this regulatory process successfully. Join us on April 30 for an insightful session! 🗓️ Further details and registration info linked below. #EUCTR #EURegulations #CTIS #EEA

More good news from PA.

Gain firsthand experience from Parexel 's regulatory experts who have made over 250 EU-CTR applications, including almost 50 transition submissions. 📋 Our EU-CTR readiness can support you in navigating the requirements of this regulatory process successfully. Join us on April 30 for an insightful session! 🗓️ Further details and registration info linked below. #EUCTR #EURegulations #CTIS #EEA

The Clinical Trials Subcommittee of the European Business Association for the second time during the full-scale war assessed the current state of clinical trials (CTs) in Ukraine and summarized the results of the industry’s work during martial law. This analysis is mainly devoted to assessing further developments in clinical trials and updating information on the current state and trends observed in the industry. Hence, among the key insights: - During the full-scale war, the clinical trials industry was negatively affected. - All participants of CTs in Ukraine continue to demonstrate a high level of reliability and quality of work, ensuring the safety of patients and the reliability of received data. - There is a further trend towards the CTs recovery in Ukraine. - The regulatory authorities, the State Expert Center of the Ministry of Health of Ukraine and the Ministry of Health of Ukraine, steadily continue to evaluate and approve CT materials, and perform regulatory supervision of CTs in Ukraine. - CT sites continue to be fully operational in the current active CTs and in new CTs that are starting. - During this time, significant steps have also been taken by all stakeholders to improve the regulation of СTs and the conditions for CTs conducting in Ukraine. All the details of the research, please, read via the link https://lnkd.in/dt3PCtdj In case of any questions, please feel free to ask – EBA Clinical Trials Subcommittee Executive Director Irina Magdik

Great presentation by Laura Pioppo EMA on the challenges and opportunities we face in the transition to EU CTR regulations. The avice is consistent: start the transition early, earlier than you thought. It is feasible, it requires expert knowledge and it will put you ahead of the competition. https://lnkd.in/eMWp2x5f

Gain firsthand experience from Parexel 's regulatory experts who have made over 250 EU-CTR applications, including almost 50 transition submissions. 📋 Our EU-CTR readiness can support you in navigating the requirements of this regulatory process successfully. Join us me on April 30 for an insightful session! 🗓️ Further details and registration info linked below. #EUCTR #EURegulations #CTIS #EEA

November 13th virtual NJNY RAPS chapter event - Revolutionizing Regulatory Collaboration: Discover the Power and Potential of Reliance Free to all RAPS members and nominal fee if not a member. Registration now open. Join us for an insightful live panel discussion, led by Dominique Lagrave, bringing together industry experts (Priti Shah, Cynthia Ban and Francesca Mangia) regulators (Claire Harrison, Chief Digital and Technology Officer at MHRA), representatives from CEPI (Debra Yeskey, Pharm.D.) and the Gates Foundation (David Mukanga), to explore the evolving landscape of regulatory collaboration and reliance. Learn from experts on how to enhance regulatory collaboration, overcome common industry challenges, and adopt reliance strategies to bring therapies to patients faster. Q&A from attendees to follow the panel discussion. #raps #chapter #regulatoryaffairs #reliance #mhra #CEPI #

Last week, the Joint Select Committee on the Legalisation of Medicinal Cannabis in South Australia released its interim report; outlining a range recommendations reached via consensus between Labor, Liberal, Independent and Greens members.     The recommended shift away from a presence-based model to an impairment-based model aligns with contemporary medical practice and goes a long way in addressing the unjust targeting of medicinal cannabis users under current laws – particularly in relation to driving and WHS.     This transition is vital for enhancing public health and ensuring equitable treatment for all.     Here are some of the key recommendations:     Amendment of Road Traffic Laws: Ensure that driving with prescribed THC is not penalised if users are not impaired. Monitoring Impairment Assessment Technologies: Prioritise the introduction of accurate methods for assessing impairment. Worker Regulations: Allow workers using prescribed medicinal cannabis to perform their duties safely, provided they are not impaired. Uniform Standards: Develop consistent dispensing, transportation, and storage requirements for medicinal cannabis across Australia. Compassionate Access Support: Provide logistical assistance to ensure broader access to medicinal cannabis products.    As we advocate for a system that supports those in need, let’s continue to champion fairness and public health in our policies. While we in the Greens certainly believe that these reforms can, and should, go further, this is a good starting place.    You can find the full report here: https://lnkd.in/gPYUGb3a