Policy & Regulation: Page 14
-
PharmaVoice Team/PharmaVoice
Personalized Medicine: From Bench To Bedside
Pharmaceutical companies are embracing the concept of personalized medicine from research and development to commercialization. Personalized medicine is the future of medicine. It will become standard in every hospital, clinic, and medical practice, supported by electronic records, decision suppo...
By PharmaVoice Team • May 29, 2014 -
PharmaVoice Team/PharmaVoice
Talent Pool
Talent Pool executive appointments and promotions in the healthcare industry Pharma Pool DR. UDIT BATRA EMD Millipore Introduces CEO and President EMD Millipore, the life-sciences division of Merck KGaA, has appointed Udit Batra, Ph.D., as president and CEO, responsible for the organization’s str...
By Ann Grey • May 29, 2014 -
Explore the Trendline➔
Stock via Getty Images
TrendlineEmerging biotech
After years of financial turmoil, the biotech market is turning the page. Strong fundamentals, including solid clinical data, are key for biotechs hoping to capitalize on the improving conditions.
By PharmaVoice staff -
PharmaVoice Team/PharmaVoice
Malaysia Focuses on Growth with Healthcare a Top Priority
Malaysia presents an attractive market to pharmaceutical companies thanks to growing government support, good infrastructure, and a trusted manufacturing environment. Malaysia is a federal constitutional monarchy with a population of about 29 million and an open and growing economy. According to ...
By Kim Ribbink • April 28, 2014 -
PharmaVoice Team/PharmaVoice
EHRs: Full of Promise But Can Pharma Play?
The opportunities within the electronic health record channel to reach physicians and patients come with many challenges for the industry. EHRs could be the promise land for the industry: a direct channel of engagement with physicians, an avenue for providing patient education, and a space to col...
By PharmaVoice Team • April 28, 2014 -
PharmaVoice Team/PharmaVoice
On the Calendar
The Calendar Industry Events and Conferences, including SPECIAL DISCOUNTS Coming Attractions ATA 2014, May 17-20, in Baltimore, brings together healthcare professionals and leading telemedicine programs to share new clinical research, best practices, and innovative business models. It is the prem...
By PharmaVoice Team • April 28, 2014 -
PharmaVoice Team/PharmaVoice
Creating Positive Communications with the FDA
Creating Positive Communications with the FDA By Denise Myshko A critical success factor in the regulatory review process is clear and frequent communications to ensure a smooth and efficient review of an application. Navigating the regulatory review process can be challenging. Industry experts s...
By Denise Myshko • March 27, 2014 -
PharmaVoice Team/PharmaVoice
Public-Private Partners For Innovation
Public-Private Partners For Innovation By Denise Myshko Partnerships with academics and the public sector have always played a significant role in research. In fact, successful private-public partnerships have led to private sector growth and innovation, job creation, and a strengthened national ...
By Denise Myshko • March 27, 2014 -
PharmaVoice Team/PharmaVoice
The Patient Experience: Keeping It Real
The Patient Experience: Keeping It Real By Robin Robinson Sidebars: The Pharmaceutical Industry Needs Emotional Insights Personal Connected Health Alliance ePUBLication Personal Connected Health: Becoming A Reality For The Life Sciences Provided by: PCHA http://bit.ly/PersonalConnectedHealth A de...
By Robin Robinson • March 27, 2014 -
PharmaVoice Team/PharmaVoice
Last Word
Last Word Educating The Next Generation John Castellani, president and CEO of Pharmaceutical Research and Manufacturers of America (PhRMA), talks about the imperative for improved science, technology, engineering, and math (STEM) education. PV: Why is STEM education so important? Castellani: Th...
By John Castellani • March 27, 2014 -
PharmaVoice Team/PharmaVoice
Talent Pool
pharma Pool Dr. John ORLOFF Merck Serono Names Head of Global Clinical Development Merck Serono has named John Orloff, M.D., as head of global clinical development. Dr. Orloff leads the design and execution of Merck Serono’s global clinical development programs and projects, driving quality execu...
By Ann Grey • March 27, 2014 -
PharmaVoice Team/PharmaVoice
Regulating in the Connected Health World
Regulating in the Connected Health World U.S. regulators have issued guidances to help bring clarity to companies considering mHealth. By Denise Myshko Regulation, by its nature, hinders some activity, says Napoleon Monroe, managing director, New Directions. “But regulation is also necessary to e...
By Denise Myshko • Feb. 25, 2014 -
PharmaVoice Team/PharmaVoice
On the Calendar
On the Calendar The Calendar Industry Events and Conferences, including special discounts Coming Attractions In May 2014, the Healthcare Businesswomen’s Association is celebrating the 25th anniversary of its prestigious Woman of the Year (WOTY) award. The HBA is proud to announce that three vis...
By Heather Hummel • Feb. 25, 2014 -
PharmaVoice Team/PharmaVoice
Singapore a Pharma Hub for Asia
Singapore a Pharma Hub for Asia By Kim Ribbink The pharma industry is increasingly drawn to Singapore, thanks to its commitment to research and innovation, good talent base, and trusted regulatory and IP environment. Singapore is fast becoming a leading regional and even global center for the lif...
By Kim Ribbink • Jan. 28, 2014 -
PharmaVoice Team/PharmaVoice
Global Regulations Becoming More Uniform
Pharmaceutical companies must navigate a changing regulatory environment both here and abroad. As the digital age brings the clinical world closer together and research and development become more global, the industry needs to find a way to address regulatory requirements across myriad regions. T...
By Denise Myshko • Jan. 28, 2014 -
PharmaVoice Team/PharmaVoice
Preparing for a Successful FDA Inspection
Pharmaceutical manufacturers need to be inspection ready, aligning their organization with the expectations of regulators. Preparing for successful inspections is not a one-time event. Being inspection ready means that pharmaceutical leaders are committed to managing compliance as part of their c...
By Denise Myshko • Jan. 28, 2014 -
PharmaVoice Team/PharmaVoice
Breakthrough Therapies: Become A Priority
Denise Myshko The FDA’s new breakthrough therapy designation pathway, which was launched in 2012, aims to streamline and speed development of products for life-threatening diseases. Many people with life-threatening diseases often have little options for treatment. Now the FDA is working with bio...
By Denise Myshko • Dec. 28, 2013 -
PharmaVoice Team/PharmaVoice
ACA: A Data Sharing Imperative
Denise Myshko The sharing of data has become a critical success factor in the healthcare market under the Affordable Care Act The Affordable Care Act changes how healthcare data need to be collected, managed, and analyzed. Accountable care organizations, providers, and payers will require connect...
By Denise Myshko • Dec. 28, 2013 -
PharmaVoice Team/PharmaVoice
Last Word
Building an Innovation Supply Chain Dr. Noubar Afeyan, managing partner and CEO of Flagship Ventures, discusses his thoughts on how pharmaceutical companies can create an “innovation pipeline." PV: What is an innovation supply chain? Afeyan: What I anticipate happening is a professionalization o...
By Dr. Noubar Afeyan • Dec. 28, 2013 -
PharmaVoice Team/PharmaVoice
R&D Collaboration: Thriving in an Era of R&D Collaboration
Thriving in a Era of R&D Collaboration Year in Preview: R&D collaboration Greater cooperation with academic and government researchers, as well as with other companies, is needed to create collaborations that push innovation forward. There is a growing consensus that the industry must tea...
By PharmaVoice Team • Nov. 13, 2013 -
PharmaVoice Team/PharmaVoice
Corporate Crystal Ball: Trends From the Top
Trends From the Top From the ACA to a value-based system, executives representing all aspects of the life-sciences industry name the top trends they believe will impact near- and long-term success. Phil Birch Senior VP, Global Strategic Marketing Aptiv Solutions 1. Value-Based System. The evolvin...
By Taren Grom • Nov. 12, 2013 -
PharmaVoice Team/PharmaVoice
On the Calendar
The Calendar MHealthSummit — where technology, business, research, and policy connect. The largest event of its kind, the fifth annual mHealth Summit, December 8-11, 2013, Gaylord National Resort and Convention Center, Washington, D.C., brings together leaders in government, the private sector, i...
By Heather Hummel • Nov. 12, 2013 -
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 -
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
Previous
