IQVIA’s Post

Don’t miss our Virtual Conference June 26-27, which explores Innovation in #RWE and Medical Affairs. Join IQVIA and industry experts for sessions discussing the value and evolving uses of RWE, regulatory guidance, and how innovation and technology can help drive efficiencies in programs to generate fit-for-purpose RWE. https://bit.ly/3Rc57xG

Your #pharma team can move faster when you have better insights. Learn how a medical director got higher-quality input from a group of global, multi-disciplinary experts. https://hubs.la/Q02zKv6k0

Learn how to optimize your trials with advice from global clinical research experts! Introducing Clinical Confidential, a new document series from MCRA’s Global Clinical Research Organization. In this series, we’ll reveal the interrelated requirements of clients developing novel healthcare technologies from a global perspective. Led by a team of industry experts and informed by the entire commercialization process, the series will help guide established companies and startups through the clinical trial labyrinth with the goal of maximizing the value of their healthcare innovations. #MCRA #clinicalresearch #medtech #medicaldevice #regulatory #machinelearning #FDAsubmission #digitalhealth Contact Us https://lnkd.in/egTEWYaV

Learn how to optimize your trials with advice from global clinical research experts. Introducing Clinical Confidential, a new document series from MCRA’s Global Clinical Research Organization. In this series, we’ll reveal the interrelated requirements of clients developing novel healthcare technologies from a global perspective. Led by a team of industry experts and informed by the entire commercialization process, the series will help guide established companies and startups through the clinical trial labyrinth with the goal of maximizing the value of their healthcare innovations.   Contact Us https://lnkd.in/eEXumAgX   #MCRA #clinicalresearch #medtech #medicaldevice #regulatory #machinelearning #FDAsubmission #digitalhealth

New Article and Video Tutorial Strategic Thinking in Medical Affairs: Approaches and Frameworks https://buff.ly/4dRLFj6 #StrategicThinking

Is Medical Affairs the Hidden Powerhouse of Biopharma? 5 Compelling Reasons It's Shaping the Future In an era where trust in pharma is under scrutiny, could Medical Affairs be the key to transformation? Here's why I believe it's time to put Medical Affairs in the driver's seat: Trust Builders: Bridging science and clinical practice, rebuilding industry credibility. RWE Revolutionaries: Leveraging real-world evidence to improve patient outcomes. Patient Voice Amplifiers: Putting patients at the center. Cross-Functional Maestros: Breaking silos, driving innovation. MA-led collaborations have accelerated personalized therapy development. Ethical Compass: Upholding standards even under pressure. Is it time we recognize the strategic value of Medical Affairs? What's your experience? #MedicalAffairs #Biopharma #HealthcareInnovation #PatientCentricity

Imagine transforming your Medical Excellence group from good to exceptional. Don’t let your strategy fall behind. Our benchmarking research, involving insights from 57 Medical leaders, reveals that success in Medical Excellence is relationship driven, staff must build trust and rapport with internal stakeholders. It is critical not to be perceived as “owning” or “dictating” excellence, but rather to listen to fellow teams, identify best practices, and pass credit along. Download our free summary to learn more about building effective Medical Excellence teams: https://lnkd.in/dnhAmUqE #MedicalAffairs #MedicalExcellence #MedAffairs #Pharma #MedicalDevices #BestPractices

Drug delivery devices have become more complex, often relying on software apps to support the patient and/or provide input to the health care professional. My colleague, medtech expert Hilde Viroux writes that there are 3 regulatory pathways for drug-device combinations and explains the pros and cons for #pharma companies in her latest article. #RegulatoryCompliance

Designing Patient-Centric Trials on a Budget: A Quantitative Framework, Upcoming Webinar Hosted by Xtalks — PRBuzz.co — #pin this #free #webinar attendees will #gain insights into strategies for optimizing the allocation of #limited resources to maximize the #impact of clinical #trials The #featured #speakers will discuss a #study #design and authoring #solution that can #help in ensuring an #effective and patient-centric #trial design. This includes strategies for optimizing the allocation of limited resources to maximize the impact of your clinical trial; techniques to identify and mitigate risks associated with #financial constraints; and #crafting trials that can adapt to financial #challenges while maintaining scientific rigor. TORONTO, May #1 #2024 #Sponsors and study #teams must navigate considerable uncertainty to ensure #safety and efficacy endpoints #meet the approval of #health authorities, regulatory agencies and payers. They must achieve this while also ensuring studies are patient-centric and that key risks are mitigated while collecting complete data to support approval. Regulatory guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

📢 𝗧𝗵𝗲 𝗳𝗶𝗿𝘀𝘁 𝗱𝗿𝗮𝗳𝘁 𝗼𝗳 𝘁𝗵𝗲 𝗻𝗲𝘄 𝗥𝗼𝘆𝗮𝗹 𝗗𝗲𝗰𝗿𝗲𝗲 (𝗥𝗗) 𝗼𝗳 𝗛𝗲𝗮𝗹𝘁𝗵 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 (𝗛𝗧𝗔) 𝗶𝗻 𝗦𝗽𝗮𝗶𝗻 𝗵𝗮𝘀 𝗯𝗲𝗲𝗻 𝗺𝗮𝗱𝗲 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝗮𝗻𝗱 𝗼𝘂𝘁𝗹𝗶𝗻𝗲𝘀 𝘁𝗵𝗲 𝗳𝗼𝗹𝗹𝗼𝘄𝗶𝗻𝗴 𝗸𝗲𝘆 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 𝗳𝗼𝗿 𝗱𝗿𝘂𝗴 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻𝘀: • The creation of a new Governance Council to oversee the new Office for the evaluation of the efficiency of health technologies and the Positioning Groups of health technologies, with the aim to separate the evaluation process from decision-making and ensure national transposition of EU directives for drug evaluations • The reinforcement of non-clinical assessments, with an increasing role of economic evaluations which will now become mandatory, and requests for disclosure of production and R&D costs • A reduction in planned assessment timelines with the aim to provide faster drug access to patients • Increasing transparency in the drug evaluation process, given the assessments will be made publicly available • Increasing engagement with manufacturers and patient and scientific societies, through participation in committees and external consultation processes throughout the evaluation process The draft RD is currently under final public consultation by relevant stakeholders and Ministry bodies and, as such, can still be subject to modifications. Once finalized and approved by all parties, the new RD is set to enter into force in January 2025. #RoyalDecreeLaw #Spain #HTA #Evaluation&DecisionMaking #MinistryofHealthSpain Become an Omakase follower for further updates