Policy & Regulation: Page 19
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PharmaVoice Team/PharmaVoice
The Physician Payments Sunshine Act: Leveraging Reporting to Build Engagement, Relationships, Trust, and Transparency
As we all know, the life sciences industry is under increased scrutiny for the money paid to physicians and other covered recipients for any marketing, consulting, speaking, and educational spend. The Physician Payments Sunshine Act, which is a part of the Patient Protection and Affordable Care A...
By Mike Haley • Sept. 27, 2013 -
PharmaVoice Team/PharmaVoice
Play Like a Team
Play Like a Team Why effective Talent Supply Chain Management is essential for the pharma company of the future Glenn Edward “Bo" Schembechler was the head football coach at the University of Michigan for 20 years, winning 13 Big Ten conference titles during his wildly successful career. Not surp...
By Mark. A Lanfear • Sept. 27, 2013 -
Explore the Trendline➔
Stock via Getty Images
TrendlineRare diseases
As drug developers find promise in the rare diseases, deals and treatments are on the rise
By PharmaVoice staff -
PharmaVoice Team/PharmaVoice
Showcase Feature: Regulatory Affairs: Regulatory Science & Regulatory Affairs
Showcase Feature: Regulatory Affairs Regulatory Science & Regulatory Affairs Regulatory affairs groups play a pivotal and ever-expanding strategic role in the success of compounds, brands, and companies, according to a report from Cutting Edge Information (CE). Regulatory teams enable organiz...
By Taren Grom • Sept. 27, 2013 -
PharmaVoice Team/PharmaVoice
Talent Pool
BIOTECH POOL Kelly BLACKBURN aTyr Pharma Expands Leadership Team aTyr Pharma has expanded its executive leadership team. Kelly Blackburn joins aTyr as VP, clinical affairs. Ms. Blackburn was formerly VP, clinical development operations, at Vertex Pharmaceuticals, where she was responsible for the...
By Ann Grey • Sept. 27, 2013 -
PharmaVoice Team/PharmaVoice
Evolving Regulations in a Globalized Industry
Evolving Regulations in a Globalized Industry Global production of FDA-regulated products has quadrupled over the last decade. Regulators and companies have to keep pace with a changing global industry. Pharmaceutical development and manufacturing have become global industries. But globalization ...
By Denise Myshko • Aug. 23, 2013 -
PharmaVoice Team/PharmaVoice
Closing the Loop on Pharma Marketing
The emergence of the iPad and similar tablets has paved the way for increasing use of closed loop marketing (CLM) throughout the pharma industry. These nimble, real-time devices enable the industry to tailor presentations, gather feedback, analyze data, and reconfigure approaches on the fly. The ...
By PharmaVoice Team • Aug. 23, 2013 -
PharmaVoice Team/PharmaVoice
The Technologists
The Technologists Brian Longo CRM Trailblazer A true trailblazer in developing flexible, customizable customer relationship marketing, Brian Longo is one of the key individuals behind Veeva’s commercial suite for the life sciences, including Veeva CRM, the multitenant cloud technology solution th...
By PharmaVoice Team • July 29, 2013 -
PharmaVoice Team/PharmaVoice
PharmaVOICE 100 - Who's on the List by Section
The Commanders & Chiefs David Berry Pronutria Damian Braga Sanofi Pasteur David Bruggeman Clinical Research Advantage Walter Capone The Multiple Myeloma Research Foundation Steve Collis AmerisourceBergen Corp. Nick Colucci Publicis Healthcare Communications Group Jim Curtis Remedy Health Medi...
By Taren Grom • July 29, 2013 -
PharmaVoice Team/PharmaVoice
2013 PharmaVOICE 100 - Who's on the List by Company
2013 PharmaVOICE 100 – Who’s on the List by Company Indexed by Company Affiliation Accelrys Ken Rapp Acorda Therapeutics Denise Duca Acurian Kristin Gross Addgene Dr. Joanne Kamens Advanced Clinical Concepts David Rear Agano Solutions and Auditgraph Mauricha Marcussen AmerisourceBergen Corp. Stev...
By Taren Grom • July 29, 2013 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
Letter from the Editor By Taren Grom The 2013 PharmaVOICE 100 Each year we have the privilege of showcasing 100 of the most inspiring and motivational individuals throughout the life-sciences industry. This special issue, now in its ninth year, once again showcases the individuals as identified b...
By Taren Grom • July 29, 2013 -
PharmaVoice Team/PharmaVoice
Count Down to the Sunshine Act
Count Down to Sunshine Act The final rule for tracking physician payments under the Sunshine Act has provided needed clarity, but questions remain about data accuracy and the public’s ability to interpret the information. The pharmaceutical industry now has some guidance on how to report payments...
By Denise Myshko • May 29, 2013 -
PharmaVoice Team/PharmaVoice
2013 DIA Preview
2013 DIA Preview This year’s theme: Advancing Therapeutic Innovation and Regulatory Science. The Drug Information Association’s 49th Annual Meeting will be held June 23 to 27 at the Boston Convention & Exhibition Center. There will be more than 250 sessions covering 22 tracks on hot topics fr...
By Taren Grom • May 29, 2013 -
PharmaVoice Team/PharmaVoice
On the Calendar
June 17-18 Gross to Net Accounting Forum for Pharmaceutical Manufacturers Hyatt Harbor Side, Boston Institute for International Research, iirusa.comJune 17-19 Next-Gen Kinase Inhibitors The Revere Hotel, Boston Cambridge Healthtech Institute, healthtech.com/kin/ June 18 5th Annual Cloud Slam 2013...
By Heather Hummel • May 29, 2013 -
PharmaVoice Team/PharmaVoice
Advancing Innovation with Better Regulatory Science
Advancing Innovation with Better Regulatory Science By Denise Myshko The FDA is in the middle of an effort to improve regulatory science and how new medicines are approved. The Food and Drug Administration is in the midst of a huge undertaking to transform the way medical products are developed, ...
By Denise Myshko • April 26, 2013 -
PharmaVoice Team/PharmaVoice
Radical Collaboration: Pharma's New Players
Radical Collaboration: Pharma’s New Players Pharma companies are taking advantage of the benefits of playing well with others. The once guarded and uber competitive pharmaceutical industry is now collaborating and sharing information with partners — both inside and outside of the industry — to sp...
By PharmaVoice Team • April 26, 2013 -
PharmaVoice Team/PharmaVoice
On the Calendar
May 16-17 Thought Leader Engagement, the Role of Medical Affairs and Medical Science Liaisons in the Era of Healthcare Reform Hyatt at the Bellevue, Philadelphia World Congress, worldcongress.com May 20-21 2nd Annual Quality Assurance in Pharmaceutical Manufacturing Conference Alexandria, Va. Q1...
By Heather Hummel • April 26, 2013 -
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 -
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
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