Navigation Links
Xtalks Life Sciences Webinar Examines Safety Assessment of Biosimilars
Date:1/15/2014

Toronto, Canada (PRWEB) January 15, 2014

This webinar will focus on EMA and FDA regulatory perspectives on nonclinical and clinical safety assessment in biosimilars.

Regulatory frameworks are evolving many countries to guide a path for biosimilar drug development, however the complex nature of biopharmaceuticals makes the demonstration of biosimilarity with regards to quality, safety and efficacy extremely challenging. Based on the specific aspects of biosimilar drug development and registration, development strategies differ significantly from the development of an innovator product that has to establish both the efficacy and safety independently from other products.

The webinar will review:

  •     EMA guidelines on Biosimilar mAbs
  •     EMA vs. FDA regulation including a discussion of WHO guidance
  •     Current global regulatory environment
  •     Case studies and ongoing challenges

A live Q&A with the audience will follow the main presentation.

For more information about this event or to register, visit: http://xtalks.com/xto706-biosimilars-safety-assessment.ashx.

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks, visit http:/
'/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2

Related biology technology :

1. The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? New Life Science Webinar Hosted by Xtalks and IRB Services
2. Pros and Cons of Adaptive Designs: A Leisurely Conversation Between a Clinician and Two Statisticians, New Webinar Hosted by Xtalks
3. A Review of Cardiovascular Pressure Sensing and Relevant Performance Specifications to Ensure Data Integrity, a New and Upcoming Webinar Hosted by Xtalks
4. Catching up with the Genomic Era in Oncology: Key Considerations for Incorporating Genomics into Oncology Drug Development, a New and Upcoming Webinar Hosted by Xtalks
5. Patient-Centric Technology for Better Trial Outcomes, a New and Upcoming Clinical Trial Webinar Hosted by Xtalks
6. UV-C Treatment—a New Procedure for Viral Inactivation, New and Upcoming Webinar Hosted by Xtalks
7. Lessons Learned in Launching a Prognostic Test Based On Tissue Image Analysis, New and Upcoming Webinar Hosted by Xtalks
8. Pharmacovigilance Benefit-Risk Assessments: Requirements, Transparency, and Implications, a New and Upcoming Drug Safety Webinar Hosted by Xtalks
9. Respiratory Update: Interpreting Minimal Clinically Important Differences in COPD and Demonstrating Product Value with PROs, a New Life Science webinar Hosted by Xtalks
10. Pharmacovigilance: ADR Management and Reporting & Outsourcing Trends, A New Drug Safety Webinar from Xtalks
11. Data-driven Site Negotiations: Fast Track to Fair Market Value (FMV), a New Clinical Trials Webinar from Xtalks
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/26/2014)... 2014 On January, 14, 2015, ... Washington D.C. science community to the UMBC campus for ... by the Protein Society, will take place from 9 ... 312. Through discussion, presentations and workshops, the free ... proteins, their role in the industry and the future ...
(Date:11/26/2014)... November 25, 2014 Whitehouse Laboratories ... joined the Morris County (New Jersey) Chamber of ... a leading business organization in the North Jersey ... further engage some key clients in the pharmaceutical ... the geographic area. Membership enables Whitehouse Laboratories a ...
(Date:11/26/2014)... Continuing its award-winning streak, Nerium International, ... MarCom Awards for outstanding creative achievement by its marketing ... Award, the organization’s top honor, in the Branding category ... in April of this year. The event showcased top ... Nerium was awarded a Gold MarCom Award in the ...
(Date:11/26/2014)... 2014 Miles Holder, formerly of Micron ... Carbon Products team as Sales/Marketing Manager. Mr. Holder has ... service for the graphite industry. , “We are thrilled ... stated Dave Trinkley, VP of Market and Product Development ... experience in the graphite industry, along with his proven ...
Breaking Biology Technology:Whitehouse Laboratories Joins Morris County Chamber of Commerce 2Whitehouse Laboratories Joins Morris County Chamber of Commerce 3Nerium International™ Wins One Platinum, Two Gold MarCom Awards 2Miles Holder Joins Graphel Corporation as Sales/Marketing Manager 2
... 2012 Hospira, Inc.  (NYSE: HSP ... infusion technologies, today announced the hiring of several new ... including the appointment of Zena G. Kaufman as senior ... role, Ms. Kaufman will have overall responsibility for Hospira,s ...
... Israel, February 13, 2012 Medisafe 1 ... that physically prevent unauthorized administration of prescription medications, announced ... of the share buyback at the beginning of the ... program approved by the BOD, Medisafe 1 Technologies is ...
... 2012 Valkee ( http://valkee.com ), the inventor ... of Oulu published the first results of the clinical and ... sensitiveness. The clinical trial, published in Medical Hypothesis ... the human brain via the ear canal. " ...
Cached Biology Technology:Hospira Names Zena G. Kaufman Senior Vice President of Quality; Strengthens Quality and Compliance Capabilities With Addition of Top Industry Talent 2Hospira Names Zena G. Kaufman Senior Vice President of Quality; Strengthens Quality and Compliance Capabilities With Addition of Top Industry Talent 3Hospira Names Zena G. Kaufman Senior Vice President of Quality; Strengthens Quality and Compliance Capabilities With Addition of Top Industry Talent 4Hospira Names Zena G. Kaufman Senior Vice President of Quality; Strengthens Quality and Compliance Capabilities With Addition of Top Industry Talent 5Medisafe 1 Technologies to Start the $1MM Stock Repurchase Program of 10MM Shares up to 10 Cents a Share 2Valkee and University of Oulu Publish the First Clinical Trial on Bright Light Therapy Channeled via ear Canals in Seasonal Depression 2Valkee and University of Oulu Publish the First Clinical Trial on Bright Light Therapy Channeled via ear Canals in Seasonal Depression 3
(Date:11/21/2014)... Nov. 20, 2014   Atmel® Corporation (NASDAQ: ... (MCU) and touch technology solutions, today launched the industry,s ... with the widest V cc range from 1.7V ... and faster I 2 C bus communication speeds, and ... memory making them ideal for consumer, industrial, computer, and ...
(Date:11/18/2014)... NEW YORK , Nov. 18, 2014 /PRNewswire/ ... iris-based identity authentication solutions, and MorphoTrust USA ... solutions and services, today announced a strategic partnership ... across enterprise, motor vehicle administration (MVA), airport screening ... leader in identity-related solutions, MorphoTrust serves consumers through ...
(Date:11/10/2014)... shelves in early 2010, and people have used them ... be tossed into a washing machine without ever having ... though, has come with risks for young children. , ... found that from 2012 through 2013, U.S. poison control ... years of age swallowing, inhaling, or otherwise being exposed ...
Breaking Biology News(10 mins):Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 2Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 3Atmel Launches Industry's First Wide-V(cc) Low-Power Temperature Sensor Family 4EyeLock, MorphoTrust Form Strategic Partnership to Pursue Commercial Enterprise Deployments 2EyeLock, MorphoTrust Form Strategic Partnership to Pursue Commercial Enterprise Deployments 3Study finds laundry detergent pods, serious poisoning risk for children 2
... DURHAM, N.C., AND SINGAPORE A multi-national research team ... identified the reason why some patients fail to respond ... Tyrosine kinase inhibitor drugs (TKIs) work effectively in most ... chronic myelogenous leukemia (CML), and non-small-cell lung cancers (NSCLC) ...
... desert Southwest becomes hotter and drier, semi-arid grasslands are ... trees, such as Prosopis velutina, and other woody shrubs, ... In a "leaf-to-landscape" approach, the team combined physiological ... to quantify how well grasslands, compared to mesquite trees ...
... squids have eyes as big as basketballs, and a Duke scientist ... huge eyes to spot and escape their predators, sperm whales," said ... of biologists to model, both physically and biologically, how and why ... the design and size of the eye give squids the ability ...
Cached Biology News:Genetic variation in East Asians found to explain resistance to cancer drugs 2Genetic variation in East Asians found to explain resistance to cancer drugs 3Mesquite trees displacing Southwestern grasslands 2Mesquite trees displacing Southwestern grasslands 3Mesquite trees displacing Southwestern grasslands 4Mesquite trees displacing Southwestern grasslands 5Basketball-sized eyes help squids play defense 2Basketball-sized eyes help squids play defense 3
... fosmid (40kb), and large plasmid insert (10-20kb) ... BAC vector. On command 20-50 fold copy ... DNA purification. Available with blue-white screening (pEZ ... the highest insert stability. Kits include electrocompetent ...
SHEEP ANTI HUMAN ESTRONE...
Anti-Goat HRP-DAB Cell & Tissue Staining Kit...
... provides all the materials necessary for the isolation ... antigen studies analysis. Kit Components: ... 5122) One bottle containing 220 mL of buffered ... (5X) - (Catalog No. 5113) One bottle containing ...
Biology Products: