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PhRMA Statement on Trump Opioids Announcement

PhRMA  |  Press Release

“America’s biopharmaceutical companies are dedicated to coming to the table with real solutions to improve our nation’s public health.
https://www.phrma.org/press-release/phrma-statement-on-trump-opioids-announcement

Week in Review: The Latest from PhRMA

PhRMA  |  Blog Post

Communications with health care professionals, advances in cancer treatment documentary, importance of safe drug disposal and more Communications with Health Care Professionals – Mit Spears, Jeff Francer and Natalie Turner of PhRMA address the key issues currently limiting communications with health care professionals in a recent article in the Food and Drug Law Journal.
http://catalyst.phrma.org/week-in-review-the-latest-from-phrma-april-3-2015

PDUFA

PhRMA  |  From PhRMA

Ensures that FDA can hire and retain a strong scientific and medical workforce to advance its public health mission.
https://www.phrma.org/advocacy/research-development/pdufa

What are REMS? These extra steps are helping protect patient health

PhRMA  |  Blog Post

Healthcare Provider (HCP) Communication Plan: as part of an HCP communication plan, the FDA may require companies to send letters informing HCPs about increased risks from medicines, share information to highlight the role HCPs can play in implementing REMS or to explain certain safety measures they must take, such as monitoring their patients during treatment.
http://catalyst.phrma.org/what-are-rems-these-extra-steps-are-helping-protect-patient-health

Center for Medicare and Medicaid Innovation

PhRMA  |  From PhRMA

It is not required to follow a formal rulemaking process or provide opportunities for public comment. 
https://www.phrma.org/advocacy/medicare/center-for-medicare-and-medicaid-innovation

PhRMA Statement on Foreign Clinical Trials - 2009

PhRMA  |  Press Release

“The PhRMA Principles for the Conduct of Clinical Trials and Communication of Clinical Trial Results, created in 2002 and updated in 2004, have been a valuable guide to member companies and underscore our commitment to the safety of clinical trial participants and communication of important medical findings from clinical trials.
https://www.phrma.org/press-release/phrma-statement-on-foreign-clinical-trials-2009

PhRMA Statement on Clinical Trials and Bad Pharma

PhRMA  |  Press Release

http://www.phrma.org/ Find PhRMA Online: Website – http://www.phrma.org Facebook – www.facebook.com/PhRMA Blog – www.phrma.org/catalyst Twitter – www.Twitter.com/PhRMAand www.Twitter.com/PhRMApress YouTube – www.youtube.com/PhRMApress For information on how innovative medicines save lives, visit: http://www.innovation.orgFor information on the Partnership for Prescription Assistance, visit: http://www.pparx.orgFor information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org
https://www.phrma.org/press-release/phrma-statement-on-clinical-trials-and-bad-pharma

Executive Assistant – Law Department

PhRMA  |  PhRMA Career

Professional Exerpience / Requirements High School Diploma required; some college education or bachelor’s degree preferred A minimum of 3+ years assisting a senior level executive preferably in a legal environment and in an environment requiring the handling of confidential information and documents Excellent communications skills, both verbal and written, including good editing skills Strong interpersonal skills, diplomacy and ability to work as a member of a team Excellent organizational skills with the ability to handle multiple tasks simultaneously Ability to work well under pressure Strong computer skills should include Microsoft Office (Word, Excel, PowerPoint, etc.) web, and database management Previous experience working with financial administrative tasks, such as financial reports and processing invoices Ability to work independently as well as lead and assist other support staff, while exercising good judgment  Ability to do some basic research; preferably have a basic understanding of legal research, processes and court filings  Who we are The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives.
https://www.phrma.org

PhRMA letter to Puerto Rico Secretary of Economic Development and Commerce

PhRMA  |  Press Release

Restoring Telecommunications, Cellular and Internet Service Limitations on service restrict communications between and among companies’ multiple plants on Puerto Rico and their ability to coordinate with employees and government agencies.
https://www.phrma.org/press-release/phrma-letter-to-puerto-rico-secretary-of-economic-development-and-commerce

New Era of Medicine: Vaccines

PhRMA  |  From PhRMA

There is significant hope for the future though, as the scientific and public health communities come together to overcome research hurdles and drive innovation for patients around the world.
https://www.phrma.org

Roy Herbst

PhRMA  |  Biography

Herbst is also a vice chair of the Southwest Oncology Group’s lung committee, a member of the medical advisory committee for the Lung Cancer Research Foundation and chair of the communications committee for the International Association for the Study of Lung Cancer.
https://www.phrma.org/biography/roy-herbst

FDA issues draft biosimilars labeling guidance

PhRMA  |  Blog Post

FDA-approved prescription drug labeling is the most authoritative mechanism for communicating information about a medicine’s safety and effectiveness to health care providers.
http://catalyst.phrma.org/fda-issues-draft-biosimilars-labeling-guidance

Robin Elliott

PhRMA  |  Biography

Active in development, communications and nonprofit management in New York City for more than 30 years, Mr.
https://www.phrma.org/biography/robin-elliott

Improve Education and Training Related to Prescription Drug Abuse

PhRMA  |  Policy Paper

In order to meaningfully address this public health challenge, enhanced tools are needed to enhance education and training across a range of stakeholders to help prevent prescription drug abuse, identify and prevent potential doctor shoppers, and identify and help refer those in need of treatment and assist those who are addicted.
https://www.phrma.org/policy-paper/improve-education-and-training-related-to-prescription-drug-abuse

Senior Director – Science and Regulatory Advocacy (Biologics and Biosimilars Advocacy)

PhRMA  |  PhRMA Career

Professional Experience / Requirements Bachelor’s degree (PhD, J.D. or other advanced degree preferred); 3+ years of relevant experience in drug discovery, development or regulatory advocacy, or related disciplines; 5+ years related work experience; Knowledge of drug discovery, development and related FDA regulations; Experience in biosimilars and biologics policy and advocacy preferred; Experience with US or international biosimilars legal and regulatory frameworks a plus; Strong project management experience and ability to handle multiple projects; Strong analytical and strategic planning skills; Excellent communication skills required:  verbal, written, listening and presentation.
https://www.phrma.org/careers/senior-director-science-and-regulatory-advocacy-biologics-and-biosimilars-advocacy1

Coalition of Texans with Disabilities

PhRMA  |  Biography

Our work revolves around legislative advocacy, public awareness events and activities, and professional services.
https://www.phrma.org/biography/coalitions-of-texans-with-disabilities

PhRMA Announces Support for Seven-Day Script Limit on Opioid Medicines for Acute Pain

PhRMA  |  Press Release

The public-private partnership would allow increased information sharing and collaboration between government and industry to speed the drug development process.
https://www.phrma.org/press-release/phrma-announces-support-for-seven-day-script-limit-on-opioid-medicines-for-acute-pain

PhRMA and BIO Initiate Litigation to Challenge Unconstitutional Provisions of Nevada’s SB 539

PhRMA  |  Press Release

Throughout this process, the biopharmaceutical industry worked in good faith with public officials on potential solutions that did not undermine incentives to invest in biomedical innovation.
https://www.phrma.org/phrma-bio-release

PhRMA Statement Regarding Drug Shortages

PhRMA  |  Press Release

In the less frequent instances when shortages occur with brand-name medicines, brand manufacturers take aggressive actions to remedy the situation, communicating with and working closely with the FDA to resolve the problems that are identified.
https://www.phrma.org/press-release/phrma-statement-regarding-drug-shortages

Supporting opportunities for enhanced competition in the marketplace

PhRMA  |  Blog Post

Accordingly, the bill would spur wasteful litigation and supplant the public health expertise of the FDA with the decisions of federal judges and would undermine patient safety.
http://catalyst.phrma.org/supporting-opportunities-for-enhanced-competition-in-the-marketplace

Week in Review: The latest from PhRMA

PhRMA  |  Blog Post

Read more about our recommended policy solutions regarding responsible communications with payers.
http://catalyst.phrma.org/week-in-review-the-latest-from-phrma-april-29-2016

Biopharmaceutical industry policies aim to increase access to clinical trial data

PhRMA  |  Blog Post

Under these Principles, biopharmaceutical companies commit to enhance data sharing with qualified researchers, share results with the patients who participate in clinical trials, enhance public access to the clinical study information and reaffirm their commitment to publish clinical trial results.
http://catalyst.phrma.org/biopharmaceutical-industry-policies-aim-to-increase-access-to-clinical-trial-data

PhRMA Statement on Dr. Scott Gottlieb’s Nomination to Lead the U.S. Food and Drug Administration

PhRMA  |  Press Release

His extensive experience as a physician and breadth of health care knowledge will help ensure the FDA continues to play a vital role in protecting public health and innovation in the Agency’s review and approval of new medicines for patients in need.
https://www.phrma.org/press-release/phrma-statement-on-dr-scott-gottlieb-s-nomination-to-lead-the-u-s-food-and-drug-administration

Dilemma Over Deductibles: Costs Crippling Middle Class

Access Better Coverage  |  From Our Network

Holly Wilson of Denver, a communications company fraud investigator who has congestive heart failure and high blood pressure, recently went without her blood pressure pills for three months because she couldn't afford them, given her $2,500 deductible.
http://www.accessbettercoverage.org/social-news/dilemma-over-deductibles-costs-crippling-middle-class

Compulsory licensing: A misused and abused international trade law

PhRMA  |  Blog Post

In 2016, the country adopted a new patent law that enables the government to grant compulsory licenses on broad public interest grounds and in circumstances where the drug is merely being manufactured outside its borders – violating terms of the WTO TRIPS Agreement.
http://catalyst.phrma.org/compulsory-licensing-a-misused-and-abused-international-trade-law

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