Maryline Legouas’ Post

In our latest white paper, IQVIA’s QPPV and Medical Information experts explore how to build a more robust model to support local pharmacovigilance and medical information activity. Download now. https://bit.ly/3xfEoJo #pharmacovigilance #medicalinformation

In our latest whitepaper, IQVIA’s Alisa Hummings and Simon Johns explore how to build a more robust model to support local pharmacovigilance and medical information activity. Download now. https://bit.ly/3ye61Tu #pharmacovigilance #medicalinformation

#EUHTA Today, the (draft) text of the first Implementing Act on Joint Clinical Assessment (#JCA) for medicinal products on which the #ComitologyCommittee expressed its positive opinion last Friday, is now available here: https://lnkd.in/ea_UqSVB The text is still a draft, awaiting formal approval by the #EUCommission. First impression is very few changes and minimal improvements. A brief insight: Art 12 : Health Tech Developer (#HTD) Dossier Submission - The time for HTD submission dossier is set at 100 days - from secretariat notification (instead of originally proposed 90 days).  - The time for HTD submission dossier in accelerated procedures and type-II variations remained unchanged, at 60 days. Art 11 : Engagement with HTD - An assessment scope explanation meeting - on the finalised scope - shall take place at the request of the HTD. - This shall take place no later than 20 days after the finalization of the assessment scope. - (in calendar days: no later than Day 150 for standard procedure, and Day 95 for accelerated procedures and type-II variations). Art 20 : Right to appeal on confidential information - The #HTA Secretariat (Commission) must provide justification to HTD on the choices of non-redaction of information considered by HTD as confidential - and inform HTD about the appeal mechanism.

Test your knowledge!🤔 What is the primary focus of 𝗠𝗚𝗜 𝗣𝗮𝗿𝗮𝗱𝗶𝘀𝗲? Drop your answer in the comments below and let's see who gets it right! 🏡🏗️ #MGI #MedicGalleriaInternational #MedicGalleria #MGIparadiseCommercial #MGIQuiz #MGIKnowledge #RealEstateTrivia #MGIExperts

We've long known that Knobbe Martens is a premier life sciences firm, but third party validation is always great, too. And I can't think of a better outlet for that than LMG Life Sciences , who shortlisted the firm in eight categories at their upcoming awards. Check out the details below! #IPLaw #LifeSciences

🎉 Exciting News! 🎉 Join me in celebrating the outstanding results of elite expertise! 🌟 Watch the video highlighting our achievements and expertise. Let's take a moment to acknowledge the hard work and dedication of our team. 🚀 #EliteExpertise #Celebration #TeamSuccess #pharmacyeducation #australia #healthcare #australia

Join Zoë Dunn on the Commercial and Marketing tracks at #REpharmaUSA today to discuss commercial strategy and precision marketing. #pharmamarketing

What after KAPS? Post Result Session With Mr. Arief Mohammad | KAPS November '23 #kaps #austalia Join Mr. Arief Mohammad in our comprehensive session as we explore the AHPRA registration pathway for pharmacists. In this pivotal discussion, we will delve into the critical steps you need to take after passing the KAPS exam, guiding you through the intricate process of securing your registration with the Australian Health Practitioner Regulation Agency (AHPRA). This session is tailor-made for international pharmacy graduates who have successfully navigated the Knowledge Assessment of Pharmaceutical Sciences (KAPS) exam and are looking to advance to the next stage of their professional journey in Australia. Mr. Mohammad will offer valuable insights into preparing your application, meeting AHPRA's stringent requirements, and what to expect during the assessment process. Whether you're uncertain about the documentation needed, the timeline for application, or how to present your qualifications and experience, this session promises to shed light on these areas and more. It's an unmissable opportunity for those aiming to practice pharmacy in Australia and seeking clarity on the AHPRA registration pathway. Don't let the complexities of the registration process deter your aspirations. Equip yourself with the knowledge and confidence to move forward in your pharmacy career by joining us this session. Watch it on: https://lnkd.in/gzdURcUd

Contract Language Review: Utilization and Quality Review Structures: 1) Are utilization review (UR) and quality review structures reasonable and clearly defined? 2)Are each party’s roles and responsibilities clearly defined? 3)Does physician have a right to independent external review? Prior Authorization/Concurrent/Retrospective Review: 1) Does the contract clearly identify (or point to specific, easily accessed electronic lists) services, drugs, or supplies that are subject to prior authorization? 2) Are procedures clear, workable, and timely (i.e. specific prior authorization processing times; urgent prior authorization process and associated processing time? 3) Does payment continue even if an enrollee loses eligibility during a course of treatment? If you are struggling with your contracting goals, book a no obligation discovery call: https://lnkd.in/eiMpBnFb

Interesting times at the CJEU. A new case before the CJEU (C-181/24, Genmab) probes the question of whether, where there is an earlier MA for a product, it is possible to disregard that MA for the purposes of Articles 3(b) and 3(d) ... on the grounds that it ceased to be valid before the date upon which an SPC application directed to the product was filed. It is tempting to speculate that, based upon principles from its earlier rulings, the CJEU will not hesitate to answer this question with a firm "No". However, it seems to me that the underlying facts of the Genmab case may give rise to a different, and much more interesting question. Article 3(b) demands that "a valid authorisation to place the product on the market as a medicinal product HAS BEEN GRANTED". Given the use of the past tense in this provision, must the MA still be valid upon the date that the SPC application is filed? In my view, there are reasonable grounds to conclude that the answer to this different question is "no". This would be a much more interesting result, and one that could lead to the grant of (albeit shorter duration) SPC protection in cases where there are earlier and later MAs for a product, but the earlier MA ceases to be valid before the later MA is granted. We shall have to wait to see whether the CJEU takes this possibility into account when considering the question referred in C-181/24. Interesting times indeed! #patents #SPCs https://lnkd.in/eFrQ7Kie