Policy & Regulation: Page 17
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PharmaVoice Team/PharmaVoice
UpFront
UpFront Podcasts Value of a Credential in the Medical Publications Profession Thought Leader: Stacy Simpson Logan, CMPP Board of Trustees, and Waterfall Consulting What is Creativity? Thought Leader: Anthony Rotolo, True Health + Wellness New Challenges for Global Clinical Trials: Managing Suppl...
By Denise Myshko • April 25, 2013 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
Inspired Leadership Pharmavoice is once again proud to support the healthcare businesswomen’s association’s (HBA) annual woman of the year event. This event, more than any other during the year, draws leaders from across the industry to celebrate the accomplishments of a distinguished group of in...
By Taren Grom • April 25, 2013 -
Explore the Trendline➔
Stock via Getty Images
TrendlineCommercialization, marketing and social media
As the pharma industry stares down a historic patent cliff, macroeconomic headwinds and challenging R&D costs for increasingly complex medicines, nailing the launch of new medicines has become increasingly critical.
By PharmaVoice staff -
PharmaVoice Team/PharmaVoice
Evolving Regulations in mHealth
Evolving Regulations in mHealth Regulators are still working to understand mobile health applications. As a result, unclear guidance is creating a challenge for pharmaceutical companies. By Denise Myshko Mobile devices have already changed the way we live and work. Now smartphones and other mobil...
By Denise Myshko • March 28, 2013 -
PharmaVoice Team/PharmaVoice
Cracking Down on Fake Drugs
Cracking Down on Fake Drugs The fight to protect the pharmaceutical supply chain is a global one, requiring law enforcement, regulatory agencies, and companies to come together for the health of patients. Counterfeit goods are big business. But when it comes to counterfeit medicines, it’s a publi...
By Denise Myshko • March 28, 2013 -
PharmaVoice Team/PharmaVoice
Improving Adherence Out of Disruption
Improving Adherence out of Disruption The industry is on the brink of one of the biggest disruptive changes in marketing history — comprehensive relationships with patients using integrated tools. By Robin Robinson The industry is facing many difficult hurdles in 2013 and beyond, but perhaps none...
By PharmaVoice Team • Feb. 27, 2013 -
PharmaVoice Team/PharmaVoice
Disrupting the Model: Patient-Centricity
Disrupting the Model: Patient-Centricity The industry may be on the verge of a dramatic change in operations to address the growing move toward putting patients at the center of, well, everything. By Robin Robinson Industry analysts have been reporting on the need for industry transformation towa...
By Robin Robinson • Feb. 27, 2013 -
PharmaVoice Team/PharmaVoice
Regulatory: PDUFA V: Beyond User Fees
A new law could help provide increased communication and transparency with U.S. regulatory authorities. The Food and Drug Administration Safety and Innovation Act (FDASIA) — a new law that went into effect in October 2012 — is expected to bring overarching changes to the review of new medications...
By Denise Myshko • Dec. 27, 2012 -
PharmaVoice Team/PharmaVoice
ACOs: A New Health Model for a New World
How healthcare is delivered to Medicare patients is changing as a result of the Affordable Care Act (ACA) of 2010. Accountable care organizations (ACOs) are groups of providers that aim to provide integrated and coordinated care to Medicare patients that is driven by outcomes, and, if successful,...
By Denise Myshko • Dec. 27, 2012 -
PharmaVoice Team/PharmaVoice
Last Word
The Last Word Promoting Healthy Aging Jack Watters, M.D., VP, external medical affairs, at Pfizer, talks about how government policies can influence the health of populations around the globe. PV: What do you think is the most significant finding of the Economist Intelligence Unit report on hea...
By Denise Myshko • Dec. 27, 2012 -
PharmaVoice Team/PharmaVoice
Talent Pool
Pharmaceutical POOL Melissa Barnes Anne Nobles Lilly Names New Ethics Chief Melissa Barnes has been promoted to chief ethics and compliance officer and senior VP president of enterprise risk management at Eli Lilly and Company. In her new role, Ms. Barnes reports to John Lechleiter, Ph.D., chairm...
By Anne Gray • Dec. 27, 2012 -
PharmaVoice Team/PharmaVoice
Marketing: Digital Media
Using Digital Media Wisely Campaigns need to follow objectives, not channels Experts say creating an experience for patients that allows them to engage with a company beyond its therapies is the most effective use of social media, delivering meaningful information to both the patient and the orga...
By PharmaVoice Team • Nov. 13, 2012 -
PharmaVoice Team/PharmaVoice
R&D: Protocols
Optimizing Clinical Trials Experts say optimizing the various processes in clinical development is critical for the timely and efficient approval of new products. Over the past several years pharmaceutical companies have been facing increases in costs and delays in conducting their clinical trial...
By Denise Myshko • Nov. 13, 2012 -
PharmaVoice Team/PharmaVoice
The C-Suite: Corporate Strategies
A New Path Ahead According to a recent Quintiles New Health report, a lack of capital and the increased reluctance of payers to reimburse for new medications are serious concerns among biopharma companies. Everyone is in agreement that the current level of healthcare spending is unsustainable, an...
By PharmaVoice Team • Nov. 13, 2012 -
PharmaVoice Team/PharmaVoice
Crystal Ball: What's Ahead
Getting Down to Business: What’s Ahead in 2013 Thought leaders from all sectors of the industry identify what they believe are the most important business objectives for the life-sciences industry and their companies for 2013 and beyond. They also provide their insights on the strategies/approac...
By PharmaVoice Team • Nov. 13, 2012 -
PharmaVoice Team/PharmaVoice
On the Calendar
The Calendar Industry Events and Conferences, including SPECIAL DISCOUNTS Coming ATTRACTIONS Social Media, Mobile & Gaming for Pharma: How To Develop, Monitor, & Execute Digital Strategies To Engage Your Audiences, Strengthen Brand Awareness & Maximize Your Communication & Marketi...
By Taren Grom • Nov. 8, 2012 -
PharmaVoice Team/PharmaVoice
Compliance Issues? First, Don't Panic.
A hurricane is coming. You heard about it on the radio. Everyone in the family jumps to it. You rush to the grocery store and pile as many cans of Chef Boyardee as will fit in your cart. Your spouse nails boards across the windows. The kids run around the house collecting candles. But when the st...
By Greg Kain • Sept. 27, 2012 -
PharmaVoice Team/PharmaVoice
SHOWCASE FEATURE: Regulatory Affairs: Regulating the Globe
The growing pressure on pharma companies and regulators to ensure and enforce product potency and safety has resulted in a strong trend toward harmonization among regulatory bodies throughout the world. “Regulatory professionals can no longer operate with a local-only mentality; every product and...
By Carolyn Gretton • Sept. 27, 2012 -
PharmaVoice Team/PharmaVoice
China's Pharma Star Shines Bright
With a large patient population, government commitment to healthcare reform, a huge depth of scientific talent, and a powerful economy, China has been identified by many as the world’s most important emerging biopharma market. With a population of 1.3 billion people, China is both the world’s mos...
By Kim Ribbink • Sept. 27, 2012 -
PharmaVoice Team/PharmaVoice
Talent Pool
Pharmaceutical Pool Dr. Lawrence Bloch Infinity Names Business Chief Lawrence Bloch, M.D., has joined Infinity Pharmaceuticals as executive VP, chief financial officer, and chief business officer. Dr. Bloch is responsible for the company’s corporate, financial, and business development strategies...
By Carolyn Gretton • Sept. 27, 2012 -
PharmaVoice Team/PharmaVoice
SHOWCASE FEATURE: Marketing: Marketing Without Wires
Throughout pharma history, marketers have always gone where the consumers are — and where they are today, in growing numbers, is on the mobile Web. An estimated 81% of physicians surveyed say they use a smartphone, while 75% specified using an Apple iPhone, iPad, or iPod, according to the Manhatt...
By PharmaVoice Team • Aug. 31, 2012 -
PharmaVoice Team/PharmaVoice
Facing the Challenges of Global Product Registration
Facing the Challenges of Global Product Registration Robin Robinson One could say keeping track of global product registrations and staying compliant with regional and international regulations is more difficult than herding cats — if that common phrase used to describe a situation where numerous...
By Robin Robinson • Aug. 30, 2012 -
PharmaVoice Team/PharmaVoice
The Era of Transparency
Now that the Supreme Court has upheld the constitutionality of the Affordable Care Act, pharmaceutical companies must continue to move forward to implement the provisions in the law. One such provision is the Physician Payment Sunshine Act, which requires manufacturers of pharmaceuticals and medi...
By Denise Myshko • Aug. 30, 2012 -
PharmaVoice Team/PharmaVoice
Hitting the Target with Behavioral Marketing
The concept of behavioral marketing is not new, but with the advent of technology and new marketing tools, the industry is able to connect with its consumers on a very individual level, creating the ability to impact behavior and health outcomes on an almost molecular scale. While data are crucia...
By PharmaVoice Team • Aug. 30, 2012 -
PharmaVoice Team/PharmaVoice
The Mentors
Kim Boericke Quintiles Tami Klerr-Naivar PRA Joe Martinez Optimer Pharmaceuticals Chuck McLeester Roska Healthcare Advertising Linda Rosenes Pfizer The Mentors Leading Through Excellence In addition to leading their organizations to reach new heights, these individuals take great pride in fosteri...
By PharmaVoice Team • July 28, 2012 -
PharmaVoice Team/PharmaVoice
Healthcare and the Political Landscape
Healthcare and the Political Landscape By Denise Myshko Healthcare reform remains front and center within the political arena. The major reforms contained in the Affordable Care Act are not scheduled to take effect until 2014, but the legislation faces legal and political challenges. In March, th...
By Denise Myshko • May 29, 2012
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