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:12/13/2014)... (PRWEB) December 12, 2014 Trend lines ... in overall global economic growth, Eugene Arthurs, CEO of ... , said in a featured talk at OPTIC (Optics ... at the National Chung Hsing University in Taichung. , ... integrated into future energy supplies and soon to hit ...
(Date:12/13/2014)... 2014 QuickSTAT is making significant investments ... Chain capabilities, and is delighted to announce the opening ... serve Life Science clients in the region. , QuickSTAT ... warehouse, will provide 24/7 transportation and logistics services, as ... patient-clinical specimens, API, following IATA rules and EU GDP ...
(Date:12/13/2014)... 12, 2014  Vaccinex Inc., a clinical-stage ... development of therapeutic monoclonal antibodies to treat ... of a manuscript entitled "SEMA4D compromises blood–brain ... neurodegenerative disease" in the January 2015 issue ... publication highlights an important role for antibodies ...
(Date:12/12/2014)... (PRWEB) December 11, 2014 Graphite Metallizing ... materials for pumps and process equipment, has appointed Kirk ... States and Ontario, Canada. Staller holds a B.S. degree ... in the industrial market place, much of it with ... out of his Michigan office. , “We are ...
Breaking Biology Technology:Photonics Continues Upward Trends Despite Challenges in the Global Economy, Notes SPIE CEO 2Photonics Continues Upward Trends Despite Challenges in the Global Economy, Notes SPIE CEO 3Photonics Continues Upward Trends Despite Challenges in the Global Economy, Notes SPIE CEO 4Photonics Continues Upward Trends Despite Challenges in the Global Economy, Notes SPIE CEO 5Quick Opens Office in France to Serve Life Science Community In France and Neighboring French-Speaking Countries 2Vaccinex announces publication of preclinical studies with an anti-SEMA4D antibody in animal models of neuroinflammatory and demyelinating disease 2Kirk Staller Joins Graphite Metallizing Corporation 2
... Total Site Solutions,(TSS), a Fortress International Group Company ... the planning, design and development of,mission-critical facilities today ... industry has awarded them the construction,management phase of ... performed technology consulting services to analyze,short term and ...
... Allos,Therapeutics, Inc. (Nasdaq: ALTH ), a biopharmaceutical ... molecule therapeutics for,the treatment of cancer, today announced ... a corporate overview at the 2007 UBS Global ... presentation will take place at 3:30 p.m. (Eastern) ...
... leader in,the rapidly evolving field of cancer molecular diagnostics, ... Lindenbergh as Chairman of its,Supervisory Board. Hessel Lindenbergh ... ING,Group N.V.. Currently, Mr. Lindenbergh is chairman of the ... the Royal Numico, Petroplus,International and Gamma Holding. Mr. Lindenbergh ...
Cached Biology Technology:Total Site Solutions Selected to Provide Construction Management Services for Existing Pharmaceutical and Biotech Customer for Data Center Expansion Project 2Total Site Solutions Selected to Provide Construction Management Services for Existing Pharmaceutical and Biotech Customer for Data Center Expansion Project 3Allos Therapeutics to Present at the 2007 UBS Global Life Sciences Conference 2Agendia BV Appoints Mr. Hessel Lindenbergh as Chairman of its Supervisory Board 2
(Date:11/21/2014)... MOUNTAIN VIEW, Calif. , Nov. 20, 2014 /PRNewswire/ ... for higher driver efficiency are piloting the North American ... the number of accidents growing, gesture recognition systems that ... will make a mark in the industry. ... of the Automotive Gesture Recognition Market in ...
(Date:11/18/2014)... , Nov. 17, 2014 The Parenteral Drug ... U.S. regulatory agencies will speak and at least seven more ... Conference at the Omni Shoreham Hotel in Washington ... once again to have significant support from the regulatory agencies ... Europe in our effort to help advance ...
(Date:11/10/2014)... appearing on U.S. store shelves in early 2010, and ... The small packets can be tossed into a washing ... or powder. The convenience, though, has come with risks ... at Nationwide Children,s Hospital found that from 2012 through ... children younger than 6 years of age swallowing, inhaling, ...
Breaking Biology News(10 mins):Gesture Recognition Intensifies with the Rise of In-car Smartphone Integration, Says Frost & Sullivan 2Gesture Recognition Intensifies with the Rise of In-car Smartphone Integration, Says Frost & Sullivan 3Gesture Recognition Intensifies with the Rise of In-car Smartphone Integration, Says Frost & Sullivan 4FDA's Janet Woodcock, EMA's Emer Cooke Headline PDA Quality Metrics Conference 2Study finds laundry detergent pods, serious poisoning risk for children 2
... a study has compared water quality trends in forested streams ... or land cover changes. The study, which draws on ... states and Puerto Rico, underscores the value of long-term data ... in streams and rivers. It is published in the current ...
... sick with colon cancer, received a blood transfusion. Then, unexpectedly, ... on her case, the French medical journal Revue D,Hmatologie identified ... it turns out, Mrs. Vel had developed a potent antibody ... of most people in the worldbut not found on her ...
... Philanthropist, businessman and community leader John Moores has given ... fund the development of a new field test for ... tens of millions of people in Africa, Latin America ... John,s generosity and foresight," said Michael A. Marletta, president ...
Cached Biology News:Study explores long-term water quality trends in near-pristine streams 2Baffling blood problem explained 2Baffling blood problem explained 3John Moores gives $2 million to Scripps Research to develop river blindness field test 2
... monoclonal antibody irreversibly crosslinked to protein G-agarose ... PDH complex from heart mitochondria. Also included ... for control immunocapture. ,The pyruvate dehydrogenase complex ... from small amounts of tissue. This facilitates ...
... innovative reagent for highly efficient transfer of ... cells. Unlike DNA transfection, with PULSin Protein ... timing of exogenous proteins in cells can ... be studied. Real time function blocking ...
... ST-195 allows real-time observations of cell cultures ... has 64 different strain parameters in addition ... thin silicon strain chamber used by the ... fluorescence microscopy. ST-195 can be used with ...
... demands on cell and tissue culture assumes ... Therefore, both cell concentration and percentage of ... precisely. The new Vi-CELLTM Cell Viability Analyzer ... to perform the trypan blue dye exclusion ...
Biology Products: