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Biosimilar Development | biosimilardevelopment.com Reviews
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Your source for Biosimilar Development. follow-on biologic or subsequent entry biologic sourcing, outsourcing and industry news. Large-Molecule solutions. Patent-ending solutions.
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Editorial Documents on Biosimilar Development
http://www.biosimilardevelopment.com/hub/bucket/mag-editorial
New Medicare Proposals Could Impact Biosimilar Competition. In early January, both Pew and MedPAC presented several suggested changes to current Medicare Part B policy. Though these two organizations proposals have their differences, the ultimate goal of both is to encourage competition between biosimilars and reference products, which would help with affordability for biologics. The 4 Most Notable Biosimilar Interchangeability Hurdles. IQPC Biosimilars Event Emphasizes Need For Regulatory Alignment.
Comparing Recent Data ManagementIntegrity Guidances From MHRA WHO PICS
http://www.biosimilardevelopment.com/doc/comparing-recent-data-management-integrity-guidances-from-mhra-who-pic-s-0001
December 13, 2016. Comparing Recent Data Management/Integrity Guidances From MHRA, WHO, and PIC/S. Over the past two years, several major regulatory authorities have published new guidance documents addressing data management and data integrity in the pharmaceutical industry. My previous article. Simply due to the comparable length of the documents, the analysis will first address the MHRA guidance (effective and draft revision). We will look at the WHO and PIC/S guidance separately. Along with the broad...
TrumpGOP Plans For Obamacare Medicare Medicaid Have Far-Reaching Pharma Effects
http://www.biosimilardevelopment.com/doc/trump-gop-plans-for-obamacare-medicare-medicaid-have-far-reaching-pharma-effects-0001
January 3, 2017. Trump/GOP Plans For Obamacare, Medicare, and Medicaid Have Far-Reaching Pharma Effects. By Paula Wade, Decision Resources Group. As US President-elect Donald Trump and emboldened Republican (GOP) Congressional leaders plan their first-100-days agenda of repealing and replacing Obamacare, they’re acting a bit like a dog that finally caught the mail truck. These three changes would substantially reduce or eliminate access to healthcare for millions of Americans and create a cascade of pote...
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Join the Biosimilar Development Community. All fields are required in order to complete this form. Please enter your email address and create a password, or register using any of your accounts below. Or create a log in with one of the providers. BRITISH INDIAN OCEAN TERRITORY. CONGO, THE DEMOCRATIC REPUBLIC OF THE. Former Rep. Of Yugoslavia (FRU). HEARD ISLAND AND MCDONALD ISLANDS. IRAN, ISLAMIC REPUBLIC OF. KOREA, DEMOCRATIC PEOPLES REPUBLIC OF. KOREA, REPUBLIC OF. LAO PEOPLES DEMOCRATIC REPUBLIC. Acces...
Life Sciences Industry Events, Conferences & Trade Shows | Biosimilar Development
http://www.biosimilardevelopment.com/eventscalendar
March 9, 2017. Communicating Beyond the Label: FDAs Latest Guidance and Updates. March 23, 2017. Quality Agreements and FDA What You Must Know to Comply with the 2016 Final Guidance. March 28, 2017. Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD) An Overview. March 29 - 31, 2017. BioTech Pharma Summit 2017. April 4, 2017. Electronic Informed Consent (eIC): How The New FDA/OHRP Final Guidance Affects You. Click on a month below to view its associated events.
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Life Science Connect - Overview
http://www.lifescienceconnect.com/index.php
Discover Life Science Connect. Life Science Connect’s vision is to facilitate connections and foster collaborations in pharmaceutical, biotech, and medical device industries. We facilitate engagement across the drug development life cycle through our web portals, publications, events, and training - learn more about our products below. Request a Media Kit. We're often asked, How can I contribute editorial for Life Science Connect? Life Science Connect Products. Is your single source for everything relate...
How Genzyme Got Its Manufacturing Mojo Back
http://www.lifescienceleader.com/doc/how-genzyme-got-its-manufacturing-mojo-back-0001
Biopharm Dev and Mfg. Pharmaceutical Dev and Mfg. Supply Chain / Cold Chain. Chief Editor Rob Wright. June 2, 2014. How Genzyme Got Its Manufacturing Mojo Back. Source: Life Science Leader. YOU MAY ALSO LIKE. Sewickley, PA 15143-8676. To continue reading this article, sign up for a free digital membership and also receive:. Articles every 30 days, from Life Science Leader. Access to industry leading content and analysis on issues shaping the pharmaceutical landscape. May exclude premium content.
2015 CRO Leadership Awards
http://www.lifescienceleader.com/doc/cro-leadership-awards-supplement-0001
Biopharm Dev and Mfg. Pharmaceutical Dev and Mfg. Supply Chain / Cold Chain. Chief Editor Rob Wright. May 4, 2015. 2015 CRO Leadership Awards - Supplement. Enjoy The 2015 CRO Leadership Awards Supplement. THIS CONTENT IS EXCLUSIVELY FOR LIFE SCIENCE LEADER. To continue reading this story and receive uninterrupted access to LSL Online and its monthly magazine subscribe to Life Science Leader. YOU MAY ALSO LIKE. Sewickley, PA 15143-8676. 1996-2016 VertMarkets, Inc.
Cardiovascular Clinical Trials
http://www.clinicalleader.com/solution/cardiovascular
Site Selection/Study Start Up. Duke and PCORI Use EHRs To Transform Clinical Trials. William Daley Joins Clinical Leader Editorial Advisory Board. WHITE PAPERS AND CASE STUDIES. Optimizing Cardiovascular Clinical Trials With Technology. Cardio-Metabolic: Clinical Development and Consultative Services. PRA Health Sciences (PRA) provides comprehensive clinical development and consultative services to support our clients’ cardio-metabolic studies. Cutting-Edge Analytics Transform Global Cardiovascular Post-...
Pain/Inflammation
http://www.clinicalleader.com/solution/pain-inflamation
Site Selection/Study Start Up. New Patch Technology Will Help Scintilla Treat Pain. Iroko Uses Event Monitoring System To Power Phase 3 Trial Of VIVLODEX. France Tragedy Reminds Us Phase 1 Researchers Must Live With Tragic Results. Will Cyclobenzaprine Be A Solution For Fibromyalgia Patients? Is There A Link Between The France Tragedy And Legal Highs? How Do I Get My Compound Into Phase I? By Dr Scott E. Boley and Greg Ruppert. WHITE PAPERS AND CASE STUDIES. Advancing Clinical Trials with Medical Imaging...
Cardinal Health Wins 1B Contract To Provide Med Devices To US Military
http://www.meddeviceonline.com/doc/cardinal-health-wins-b-contract-to-provide-med-devices-to-u-s-military-0001
August 10, 2015. Cardinal Health Wins $1B Contract To Provide Med Devices To U.S. Military. Follow me on Twitter @jofenriq. DoD also awards $240 million contract to Owens and Minor Distribution Inc. for medical and surgical supplies. Cardinal Health has secured a $1 billion contract with the United States Department of Defense (DoD) to provide medical devices and supplies to U.S. military services and federal civilian agencies. A DoD press release. In a recent news release that fourth-quarter fiscal year...
Rapid Manufacturing For Metal Components
http://www.meddeviceonline.com/doc/rapid-manufacturing-for-metal-components-0001
August 4, 2015. Rapid Manufacturing Of Metal Components For Medtech Applications. VP and GM of the Americas, Proto Labs. In my previous post. To start, let’s look at some of the frequently used metals. From harder to softer, this range of metals includes steel, stainless steel, aluminum, brass, and copper. Magnesium flakes, ready for fabrication. Steel And Stainless Steel. Metal Injection Molding (MIM) And Thixomolding. For increased metal part production, machined components are often transitioned to ca...
Philips Healthcare A New Approach To Innovation
http://www.meddeviceonline.com/doc/philips-healthcare-a-new-approach-to-innovation-0001
August 4, 2015. Philips Healthcare: A New Approach To Innovation. It is not an idea problem but a cultural one, as evident in the following quote from a recent research report on innovation from PricewaterhouseCoopers, LLC: “Medtech executives expect a higher level of breakthrough and radical innovations in solutions and business models over the next three years, but just 14 percent say they have a coordinated plan to achieve that goal.”. What is your company’s innovation plan? Med Device Online (MDO):.
Make vs Buy Decision Simplified
http://www.meddeviceonline.com/doc/make-vs-buy-decision-simplified-0001
July 22, 2015. Make vs. Buy Decision: Simplified. Get the latest articles from Med Device Online delivered to your inbox. YOU MAY ALSO LIKE. 425 N Martingale Road, Suite 2050. Schaumburg, IL 60173. Life Science Leader Magazine. Life Science Training Institute. 1996-2016 VertMarkets, Inc.
Imaging In The Worst Possible Environment
http://www.meddeviceonline.com/doc/imaging-in-the-worst-possible-environment-0001
March 25, 2015. Imaging In The Worst Possible Environment. This case study explains how they leveraged Zygo’s expertise as it relates to engineering and manufacturing precision electro-optical assemblies to see the dental imaging device from concept to volume manufacturing, while overcoming the challenges they had with their 3D dental wand’s design. Get the latest articles from Med Device Online delivered to your inbox. YOU MAY ALSO LIKE. Middlefield, CT 06455-0448. Life Science Leader Magazine.
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biosimilar.org - This website is for sale! - biosimilar Resources and Information.
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Biosimilar Development
Is An FDA Pre-IND Meeting Worth It? How To Decide and How To Prepare. If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity. Why Real-World Evidence Will Challenge Biosimilars. How To Think Bigger About Biosimilars. Top 5 Biosimilar Developments Of 2016. The first article in this series, Risk-Bas...
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biosimilardrugs.com - This website is for sale! - biotechnology pharmaceutical drug biosimilar Resources and Information.
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Biosimilar Drugstore
Welcome to biosimilardrugstore.com. Is an important domain name for a mass market prescription drug retailer or pharmacy benefits management (PBM) organization. As access to biosimilars. And other follow-on biologics. Expands in the coming years, this domain name will be ready to serve a pharmacy or PBM organization that is ready to support this vital area of medicine. Further information on domains in this area can be found at FollowOnBiologic.com. THIS DOMAIN NAME IS FOR SALE. Top Chops on the Net.
Biosimilare Antikörper – Neue Herausforderung in der Onkologie
EUROFORUM Jahrestagung, 18. November 2014. Biosimilare Antikörper Neue Herausforderung in der Onkologie. Noch viele offene Fragen. Ärzte beurteilen abgekürztes Zulassungsverfahren skeptisch. Plädoyer für erweiterte Pharmakovigilanz. Unklar ist, ob sich für eine die Effektivität einschließende, erweiterte Pharmakovigilanz Finanzierungswege finden lassen. Dr. Johannes Bruns, Deutsche Krebsgesellschaft, brachte eine Evaluierung und Finanzierung im Kontext des Off-Label-Paragraphen 35c, SGB V ins Ges...Entsc...
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