Policy & Regulation


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    Diego Camargo/PharmaVoice

    Welcome to the new PharmaVoice

    A similar mission, a new format, and our plans for PharmaVoice's next chapter.

    By Davide Savenije • Jan. 13, 2022
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    Dan Kitwood via Getty Images

    5 trends shaping clinical trial regulations in 2022

    As agencies respond to innovations in pharma, notable shifts in 2022 are on the way.

    By Jan. 11, 2022
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    PharmaVoice Team/PharmaVoice
    Profile

    Regulators

    Navigating the regulatory landscape, while ensuring quality and transparency, requires skillful leadership and knowledge. The rebel in the room, doesn’t stay in her lane Blazing new trails to… continue to elevate the need for equity in healthcare Amanjot Kaur Khera Title: ...

    By PharmaVoice Team • Aug. 1, 2021
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    PharmaVoice Team/PharmaVoice

    Getting Real with RWE

    Real-world evidence, important for regulatory decision-making, is beginning to touch all areas of the healthcare value chain. Historically, real-world evidence (RWE) and real-world data (RWD) have been used for postmarket safety monitoring, but now sponsors are beginning to use these data sets to...

    By Taren Grom • Nov. 16, 2020
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    PharmaVoice Team/PharmaVoice

    The New Virtual Engagement Reality

    COVID-19 has created a virtual environment that is here to stay, and the industry will need to begin to adjust. From remote working to patient and physician engagement, pharma marketers and sales reps have had to rethink commercial strategies in a virtual landscape. With the onset of COVID, the s...

    By Robin Robinson • Nov. 16, 2020
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    PharmaVoice Team/PharmaVoice

    What's Next Post-COVID-19: The Next Normal

    From R&D to commercial operations, stakeholders across the healthcare ecosystem are adjusting to the next phase of the pandemic: business in a new reality. With some experts predicting that the “normalization" of business operations could be several months to a year away as the world awaits a...

    By PharmaVoice Team • Sept. 1, 2020
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    PharmaVoice Team/PharmaVoice

    Commanders & Chiefs

    These forward-thinking leaders are strategically positioning their companies for success and inspiring their teams to achieve far-reaching goals as they navigate complex industry challenges. Dr. Reshma Kewalramani Breaking Barriers Raising the bar… by making the impossible, possible. Title: CEO a...

    By PharmaVoice Team • Aug. 1, 2020
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    PharmaVoice Team/PharmaVoice

    Entrepreneurs

    These visionary leaders recognized an opportunity to fill an industry need and are successfully leading their companies to new heights. Game Changer Raising the bar… by proving what is possible in accelerating clinical drug development Michelle Longmire, M.D. Title: CEO and Co-Founder Company: Me...

    By PharmaVoice Team • Aug. 1, 2020
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    Change Agents

    These forward-thinking individuals are disrupting the status quo and setting the strategic direction for their companies to capitalize on the opportunities that will shape the future of the healthcare ecosystem. Answering the Innovator’s Dilemma Raising the bar… by knowing what is achievable Crai...

    By PharmaVoice Team • Aug. 1, 2020
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    Patient Champions

    These patient-focused leaders are re-imagining what patient engagement is and what it can be for their organizations and the industry at large. Going the Extra Mile for Rare Disease Patients Raising the bar… to be better than the day before Mary Frances Harmon Title: Senior VP, Corporate and Pati...

    By PharmaVoice Team • Aug. 1, 2020
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    Mentors

    These champions of diversity and inclusion are dedicated to developing the next generation of leaders and setting an example for others to follow. An Ally for All Raising the bar… by bringing people together Peter Anastasiou Title: Executive VP & Head of North America Company: Lundbeck Indust...

    By PharmaVoice Team • Aug. 1, 2020
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    PharmaVoice Team/PharmaVoice

    A New Era of Clinical Trials

    The future is now, and how the industry responds to the COVID-19 pandemic will set the course for drug development for years to come. The COVID-19 pandemic has created disruption across every aspect of the world. The clinical trial ecosystem is no exception — from drug discovery through to regula...

    By PharmaVoice Team • June 1, 2020
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    PharmaVoice Team/PharmaVoice

    Age of the Machine: Using Algorithms to Advance Outcomes

    Machine learning is being applied across the industry to support decision-making in clinical trials, R&D, regulatory, and commercial processes. What’s the difference between machine learning and artificial intelligence? The answer lies in the word intelligence, since AI is about enabling mach...

    By Kim Ribbink • June 1, 2020
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    PharmaVoice Team/PharmaVoice

    Clinical Experts

    These clinical development experts are redefining clinical operations to increase efficiencies, reduce costs and timelines, and improve the safety profiles of bringing new medicines to patients. A Rare Passion for Patients Energetic. Unrelenting. L. Mary Smith, Ph.D. Title: Senior VP, Clinical R&...

    By PharmaVoice Team • Aug. 1, 2019
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    Brand Bonds

    Trust is the glue of agency/client relationships, and communication is the foundation. Browse a few pharma marketing agency websites and you can learn about the number of awards won, the big name clients, the years in business, the expertise; but where is the link for “Good at Relationships?" One...

    By PharmaVoice Team • May 1, 2019
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    Patient-Based Culture

    Companies need to cultivate patient-centricity from the inside out. Not much more than five years ago, UCB was one of the first pharma companies to bring patient centeredness deep into its culture, moving away from the traditional product-based model driven by revenue growth and sales toward the ...

    By PharmaVoice Team • April 1, 2019
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    The Evolving Role of Patient Advocates

    Patient advocacy groups have long had relationships with pharma, and now, individual patients are also sharing their voices and their power. While pharma has long had relationships with advocacy organizations, there is a growing wave of individual patients who are willing to speak up, be engaged,...

    By PharmaVoice Team • April 1, 2019
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    Patient-Focused Drug Development

    Biopharma companies and regulators are working to put the patient truly at the center of drug research and development. Empowered patients are redefining the healthcare environment on their own terms. Today, patients and advocates are playing a more central and proactive role in managing their ow...

    By PharmaVoice Team • April 1, 2019
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    Patients and Regulatory Support

    Regulators are working to make sure patients have a seat at the clinical trial table. The Food and Drug Administration has been instrumental in the movement toward patient-centric clinical trial initiatives and driving these initiatives forward is the future of trial development. In recent years,...

    By Denise Myshko • April 1, 2019
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    PharmaVoice Team/PharmaVoice

    Clinical Experts

    Nariman Nasser For Creating Opportunities for Sites Title: VP, Site Engagement Company: Continuum Clinical Education: BS Microbiology, Arizona State University Hobbies: Swimming, biking, snowboarding, and anything outdoors that provides an adrenaline rush Associations: SoCRA, DIA, ACRP Social Med...

    By PharmaVoice Team • Aug. 1, 2018
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    Regulators

    Dr. Joanne Palmisano For Advancing Regulatory Affairs Title: VP, Regulatory Affairs Company: Boehringer Ingelheim Pharmaceuticals Inc. Education: MD, Columbia University, College of Physicians & Surgeons Family: Husband Russ; sons Robert and Michael — without their patience and support she wo...

    By PharmaVoice Team • Aug. 1, 2018
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    PharmaVoice Team/PharmaVoice

    Transformation: Is the Industry Ready?

    Although the pharma industry scored pretty low on a McKinsey scale of digital maturity, there is evidence that it is moving — perhaps only incrementally — toward a digital transformation that can streamline processes, generate collaboration, and coordinate data collection. The pharma sector, not ...

    By PharmaVoice Team • June 1, 2018
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    PharmaVoice Team/PharmaVoice

    Patients' Voices

    PharmaVOICE editors have been writing about patient-centricity and all this topic encompasses for what seems like a decade. Some say the term has lost meaning because of its ubiquituous use. We contend that patients are leading the way and influencing how businesses operate today. For sure, there...

    By PharmaVoice Team • April 1, 2018
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    PharmaVoice Team/PharmaVoice

    Technology and Patient-Centric Trials

    The term patient-centric is about ensuring the needs and perspectives of the patients are taken into consideration while maintaining scientific rigor for a clinical trial. Pharmaceutical sponsors have begun engaging patients in the trial design, seeking input and acknowledging the importance of t...

    By PharmaVoice Team • April 1, 2018
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    Patient-Centered Apps

    The pharmaceutical industry is up against several challenges when it comes to developing mobile apps for its consumers. According to Deloitte, issues of consumer trust, app design, and regulatory concerns can throw up roadblocks in the very crowded and competitive field of 300,000-plus healthcare...

    By PharmaVoice Team • April 1, 2018