Policy & Regulation: Page 3


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    Women & Health: Lessons in Leadership

    Currently, executive women hold only about 4.6% of CEO positions in S&P 500 companies. Research from McKinsey & Company reports that at the first critical step up to manager, women are 18% less likely to be promoted than their male peers. This gender disparity has a dramatic effect on the...

    By PharmaVoice Team • March 1, 2018
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    Tackling Regulatory Challenges in a Tighter Global Marketplace

    When it comes to pharmaceutical regulations, change is constant. Regulatory authorities have become more cautious with product approvals, there are increased demands for more comprehensive data, digital is creating new opportunities and challenges, and globalization of the industry means companie...

    By PharmaVoice Team • Feb. 1, 2018
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    Gender Parity

    A recent McKinsey report reveals that women remain underrepresented at every level in corporate America, despite earning more college degrees than men for 30 years and counting. There is a pressing need to do more, and most organizations realize this: McKinsey reports that company commitment to g...

    By Taren Grom • Feb. 1, 2018
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    Disruptive Advertising

    Technology disruptions in our world are becoming routine, and consumers are becoming impervious to the daily assault on their attention. In order to be effective, brand marketers need to rise above and beyond an ever-rising bar of campaign creativity, as well as use technology to break through al...

    By PharmaVoice Team • Jan. 1, 2018
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    Industry Gears Up For Track and Trace

    Counterfeit medicines have taken a huge toll, both in terms of human costs as well as financially. Interpol estimates that 1 million deaths each year can be linked to counterfeits. According to PwC, counterfeit pharmaceuticals are a $200 billion-plus annual business. The problem is most severe in...

    By Kim Ribbink • Jan. 1, 2018
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    A Rare Journey: Managing the Regulatory Landscape

    In 1983, Congress passed the Orphan Drug Act, bringing with it the opportunity to advance the development of drugs for rare diseases. Since that time, the Food and Drug Administration (FDA) has approved more than 550 products to treat rare diseases. The FDA established the Office of Orphan Produc...

    By Kim Ribbink • Oct. 1, 2017
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    The Battle Against Infectious Disease

    Epidemics of infectious diseases are a real and dangerous threat. Nowhere in the world have infectious diseases been addressed adequately to become a small portion of illness and death. The Ebola and Zika public health emergencies have brought to light that we are unprepared to detect, prevent, a...

    By Denise Myshko • Oct. 1, 2017
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    Letter from the Editor

    Storied Careers This is my favorite issue of the year — nothing against the other great issues we put out every month. But there is something particularly special about showcasing 100 men and women who have dedicated their lives to the life-sciences industry. They could be using their talents in ...

    By Taren Grom • Aug. 1, 2017
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    Who's On The List by Section

    This article contains the list of 100 honorees. If you want to read the article featuring a particular person, please view the Section in which he/she is featured. Change Agents Danielle Bedard inVentiv Health Kathy Biberstein Alkermes Kim Carpenter HCB Health Dr. Ryan Cohlhepp Takeda Oncology Su...

    By PharmaVoice Team • Aug. 1, 2017
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    The Researchers & Scientists

    Dr. Daniel Auclair Bridging the Cancer Gaps Title: Senior VP, Research Company: Multiple Myeloma Research Foundation Education: BS, Biochemistry, MSc, Biochemistry, University of Montreal; PhD, Nutrition/Biochemistry, Dana-Farber Cancer Institute/Harvard Cancer Center Family: Father — lost to an ...

    By PharmaVoice Team • Aug. 1, 2017
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    The Technologists

    Steve Powell Tackling Technology Innovation with a Patient-Focus Title: Executive VP of Trial Oversight Company: ERT Education: BSc (Hons),  Mathematics, University of Wales, Cardiff Family: Lori, his wife who supports him in the career decisions and the changes he makes; Betty and Eddie, his mot...

    By PharmaVoice Team • Aug. 1, 2017
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    Responding to Increased FDA Focus on Data Integrity

    As clinical trials grow in complexity and new technologies emerge for capturing clinical data, the need to improve sustainability of data integrity throughout study conduct has heightened. Over the past five years, the volume of data integrity-related CGMP violations have grown in prevalence. In ...

    By Don Zinn • June 1, 2017
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    C-Suite Outlook: Leading Through Extraordinary Change

    Sustaining Value According to Deloitte, life-sciences companies are evolving their business models from product development through manufacturing and distribution, to move “beyond the pill"  and to engage more fully with providers and patients throughout the product lifecycle and “transform what ...

    By PharmaVoice Team • Feb. 1, 2017
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    Global Expedited Review

    Following the implementation of the Food and Drug Administration’s  Breakthrough Therapy Designation in 2012, both the European Union’s and Japan’s regulatory agencies began the process of determining how to provide an expedited review for therapies for serious diseases with unmet needs. The resu...

    By Denise Myshko • Jan. 1, 2017
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    What's New

    FDA Issues Guidance on Registering Clinical Trials  Trending now: A new rule takes steps to provide more information about clinical trials to the public. In an effort to make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services in Sept...

    By PharmaVoice Team • Nov. 21, 2016
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    Trending 2017: The Cancer Moonshot

    Launched in January 2016, the White House’s Cancer Moonshot is a $1 billion initiative to jump-start the effort to eliminate cancer. A large part of this initiative is the development of cancer immunotherapies. In October 2016, Vice President Joe Biden delivered the Cancer Moonshot report that la...

    By PharmaVoice Team • Nov. 21, 2016
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    Change Agents

    Alison Little Title: Principal, Advisory Industry Leader for Life Sciences Company: KPMG LLP Education: BS, Materials Science & Engineering, Johns Hopkins University Family: Parents; husband; two children Hobbies: Cooking, yoga, spending time with family and friends Bucket List: Travel with f...

    By PharmaVoice Team • Aug. 1, 2016
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    The Patient Advocates

    Lise J. Hall Title: Associate Director of Consumer Marketing, Lung Cancer Franchise Company: AstraZeneca Education: MBA, Ross School of Business, University of Michigan Family: Dad, mom, sister, Angélique, brother, Daniel Hobbies: Home renovation, cooking and eating, discovering new cultures Buck...

    By PharmaVoice Team • Aug. 1, 2016
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    Red Jacket Awards

    2016 Red Jacket Honorees Inspired leaders for today and tomorrow In 2014, to mark the milestone of the 10th anniversary of the PharmaVOICE 100, we initiated our version of a “hall of fame" — the Red Jacket Awards. One of the criteria for being named a Red Jacket is having been recognized as a Pha...

    By PharmaVoice Team • Aug. 1, 2016
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    The Changing Clinical Landscape

    Clinical operations — the department that manages the operational aspects of clinical studies — is facing increased challenges: compressed timelines; increased competition for sites and patients; more complex study protocols; increased regulatory expectations; and new technologies and industry st...

    By PharmaVoice Team • June 1, 2016
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    HBA Rising Stars: Healthcare Vision 2020

    PharmaVOICE has exclusive access to nearly 100 women leaders, who are providing their take on the trends that are expected to shape the healthcare industry in the next four years. Identified by their companies as HBA Rising Stars and Luminaries, these industry executives talk about everything fro...

    By PharmaVoice Team • May 1, 2016
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    Pharma Trax

    Adverse Drug Event Reporting in U.S. Plagued by Incompleteness and Inaccuracy Trending now: A high proportion of healthcare professionals have no ADE reporting experience. Voluntary adverse drug event (ADE) reporting in the United States is incomplete, inaccurate, and inefficient, which could den...

    By PharmaVoice Team • Jan. 1, 2016
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    Tools of the Trade

    PerkinElmer Launches Signals for Translational    Trending Now:  New cloud-based informatics platform supports complete precision medicine workflow. PerkinElmer has launched PerkinElmer Signals for Translational, a cloud-based data management, aggregation, and analysis platform for pharmaceutical...

    By PharmaVoice Team • Jan. 1, 2016
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    21st Century Cures Act

    The 21st Century Cure Act, if passed, promises to promote the development and hasten the approval of new drugs and devices, especially treatments for cancer and rare diseases. It puts the view of the patient in the center of drug discovery, development, and delivery, balanced by insights derived ...

    By Robin Robinson • Nov. 15, 2015
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    Precision Medicine: Patient-Centric R&D

    President Obama unveiled early in 2015 the Precision Medicine Initiative, an effort to revolutionize medicine and generate the scientific evidence needed to move the concept of precision medicine into everyday clinical practice. With a $215 million investment in the President’s 2016 budget, the P...

    By Denise Myshko • Nov. 15, 2015