PharmDedict

European Medicines Agency and the Heads of Medicines Agencies (HMA) have published high-level principles and recommendations for all staff across the European medicines regulatory network (EMRN) using large language models (LLMs) in their work. 📌 The guiding principles cover various aspects of using LLMs, from ensuring safe input of data, to applying critical thinking and cross-checking outputs, to knowing whom to consult when concerns arise. 📌 Responsible use of LLMs requires familiarity with the tools. The importance of continuous learning is emphasised to keep pace with the fast-changing field. Full document 👉 https://lnkd.in/dVxrbSP6.

💊 Collaborative project management is transforming how regulatory affairs (RA) consultancies navigate the increasingly complex pharmaceutical landscape. 📌 At PharmDedict, we ensure your products move smoothly through complex regulatory pathways like DCP and MRP, bringing them to market quickly and compliantly. Our experience and expertise make us the trusted partner for your RA needs. Curious to learn more? 👉 https://lnkd.in/dPybMZ8f

Gergana Semova and Rahila Kozarova will represent PharmDedict at CPHI 2024 in Milan. 📌 We aim to strengthen our relationships with trusted partners and attract new ones. 📌 We seek stable partnerships for Decentralized Procedure and Mutual Recognition Procedure project management, aiding EU medicinal product registration. 📌 We are open to discussing regulatory support with pharmaceutical companies entering the EU market, especially in BG, RO, and CEE. Looking forward to seeing you at #CPHIMilan!

European Medicines Agency: The new revision 3 of the Guideline on good #pharmacovigilance practices (GVP), Module XVI (Risk minimisation measures), comes into effect. 📌 The revised final guidance is applicable to new applications for marketing authorisation, new risk minimisation measures, and new studies evaluating risk minimisation measures for authorised medicinal products. However, it is not immediately applicable to existing risk minimisation measures and ongoing activities regarding risk minimisation measures. 👉 https://lnkd.in/dCisAH7t

📢EMA's human medicines committee, the #CHMP, recommended 1️⃣ 4️⃣ new medicines for approval in the EU. ☑️ 1 medicine for chronic hand #eczema ☑️ 1 medicine for dry eye disease ☑️ 5 medicines to treat #cancer 👉 https://lnkd.in/dJrwY9Qg #PublicHealth

Significant amendments to Ordinance No. H-6 were promulgated on July 5, 2024, affecting the Bulgarian National Health Information System (NHIS). Key changes: 📌 Mobile access through “eHealth” mobile app. 📌 New identification methods. 📌 Better control over personal data These updates will improve transparency, patient communication, and personal data security. Discover more about these impactful changes. 👇

At PharmDedict, we are committed to developing our organization and enhancing the capacity of our people by following to our core values and behaviours: 📌 We know regulation. 📌 We fall in love with the problems. 📌 We take it personally. Orin Chisholm and Helen Critchley outline the essential skills for future readiness of regulatory affairs professionals in their article, "Future Directions in Regulatory Affairs." Yes, we agree... Read more here: 👉https://lnkd.in/eNKf2vM3.

In a recent article published in Frontiers in Medicine, experts explore the current trends shaping the development of new therapies aimed at alleviating diseases, and the consequential impact on the role of regulatory affairs professionals. The article also highlights the challenges these professionals face and offers insights to help them stay ahead of these trends and effectively prepare for their influence on their professional responsibilities. Full article by Orin Chisholm and Helen Critchley 👉 https://lnkd.in/eNKf2vM3

📢 We're #hiring a new Senior Regulatory Affairs Specialist in Sofia. 👉 Apply today or share this post with your network. 👍