Navigation Links
Webinar on Clinical, Regulatory and Commercialization Strategies for Rare Diseases
Date:1/9/2013

Toronto, Canada (PRWEB) January 09, 2013

Throughout the clinical development and commercialization lifecycle of products to treat rare diseases, there are a variety of clinical studies that can be conducted. Studies may be conducted for various reasons including product regulatory approval, patient access to a product for an unmet need, patient registries, or as a post-marketing requirement following product approval. The regulatory strategy employed often dictates the type of study that needs to be conducted to address an associated regulatory requirement.

Key Learning Objectives:

  • US Regulatory requirements and associated study design - Registries, pre-, post-, and peri-approval designs
  • EU regulatory environment and Compassionate Use/Expanded Access Programs (EAP)
  • Real World case examples and lessons learned

For more information about this event or to register, visit: http://xtks.in/xto520

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://xtalks.com/ContactUs.ashx

Contact:
Karen Lim (416) 977-6555 ext 227
clientservices(at)xtalks(dot)com

Read the full story at http://www.prweb.com/releases/2013/1/prweb10298234.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1

Related biology technology :

1. Northeastern University Nanomanufacturing Center Director Ahmed Busnaina to Present Webinar on “The Democratization of Manufacturing”
2. Webinar Announcement: GenomeSpace: A New Solution for Integrating Genomic Analysis Tools
3. Best Practices, LLC Issues New Report and Webinar on Managing Healthcare Reform through Effective Engagement with the Government Ecosystem
4. BioPharm Systems to Host Webinar on Self-service Account Management for Oracle Clinical, Remote Data Capture, and Thesaurus Management System
5. The Veterinary Bioscience Institute Announces an Amazing Series of 41 Webinars for 2013
6. The Veterinary Bioscience Institute Announces its January 2013 Webinar Schedule
7. Agility Clinical, Inc., a Specialty Contract Research Organization is Formed
8. Healthcare Cloud Computing (Clinical, EMR, SaaS, Private, Public, Hybrid) Market - Global Trends, Challenges, Opportunities & Forecasts (2012 - 2017)
9. Generex Provides Update on Generex Oral-lyn™ Clinical & Regulatory Program
10. Generex Subsidiary Antigen Express Provides Update on AE37 Cancer Vaccines Clinical & Regulatory Strategy
11. ADVENTRX Announces Establishment of Regulatory Advisory Board
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... 2014 Decision Resources Group finds that the ... 12 percent compound annual growth rate through 2023. This ... and the increasing adoption of dental implants. Growing aesthetic ... also spur demand for dental biomaterials because they can ... treatments. Other key findings from Decision Resources ...
(Date:12/19/2014)... 2014 Today, TiFiber, Inc. ... production facility and future company headquarters in Fort ... new materials that safely and effectively control dangerous ... of its historic, strong support for manufacturing, but ... leading edge, technology-based companies such as TiFiber. ...
(Date:12/19/2014)... 18, 2014 Reports from CDC ... States suffer from one or more chronic health conditions ... Medication can address some of these diseases, but may ... many sufferers face. While implanted nerve stimulation devices today ... whole nerve, which can induce side effects. , ...
(Date:12/19/2014)... December 19, 2014 The empty ... the rising ageing population and technological innovations in ... nutraceutical industries are catalysing the growth of the ... http://www.marketsandmarkets.com/Market-Reports/empty-capsules-market-218018190.html , Scope of Report , ... well as new entrants/smaller firms to gauge the ...
Breaking Biology Technology:Latin American Dental Biomaterial Market Will Expand at a 12 Percent Annual Growth Rate Through 2023 2Latin American Dental Biomaterial Market Will Expand at a 12 Percent Annual Growth Rate Through 2023 3Technology Company TiFiber™ to Establish Production Facility in Fort Smith, Arkansas with Support from Local Investors 2Technology Company TiFiber™ to Establish Production Facility in Fort Smith, Arkansas with Support from Local Investors 3Technology Company TiFiber™ to Establish Production Facility in Fort Smith, Arkansas with Support from Local Investors 4Draper Wins GSK Funding for Smaller, Smarter Implantable Devices 2Empty Capsules Market Hit to Reach $1,820 Million by 2019 - New Research Report by MarketsandMarkets 2Empty Capsules Market Hit to Reach $1,820 Million by 2019 - New Research Report by MarketsandMarkets 3Empty Capsules Market Hit to Reach $1,820 Million by 2019 - New Research Report by MarketsandMarkets 4
... Experts ... Life Sciences industry , ... Wayne, PA (PRWEB) February 2, 2010 -- MODA Technology Partners, a global ... industry, today announced four new members to its product advisory board focused on improving ...
... EXTON, Pa. , Feb. 2 ... company focused on the development of regenerative cell therapy ... David Pernock , Chairman of the Board of ... immediately. Pernock most recently served as Senior Vice President ...
... , SANTA ROSA, Calif. , ... EcoNugenics introduces the newest in their scientifically ... Rosa, CA -based nutraceutical company, founded in 1995 by integrative medicine pioneer, ... has once again demonstrated excellence in being at the forefront of the ...
Cached Biology Technology:MODA Names New Members to QC Micro Advisory Board 2Fibrocell Science, Inc. Names David Pernock Chief Executive Officer 2Fibrocell Science, Inc. Names David Pernock Chief Executive Officer 3Just in Time for Heart Health Month... TRIPLE Cardiovascular Health Support From EcoNugenics 2Just in Time for Heart Health Month... TRIPLE Cardiovascular Health Support From EcoNugenics 3
(Date:12/19/2014)... , Dec. 18, 2014  23andMe, Inc., the leading ... study that pinpoints fine-scale differences in genetic ancestry of ... . Since immigrants first arrived more than ... has served as a meeting place for ... history and the ongoing mixing of peoples with African, ...
(Date:12/17/2014)... , Dec. 15, 2014  HITLAB SM ... Practices (GCP) audit to confirm its adherence to ... This accomplishment enables HITLAB to conduct regulated smart ... highest principles for patient safety and research quality. ... healthcare access, quality, and delivery with innovative technology," ...
(Date:12/15/2014)... --Research and Markets ( http://www.researchandmarkets.com/research/87pph8/global_facial ) ... Facial Recognition Market 2015-2019" report to their ... Facial recognition is a technology used ... measures the overall facial feature of a person ... distance between eyes. Facial recognition is used for ...
Breaking Biology News(10 mins):23andMe Study Sketches Genetic Portrait of the United States 223andMe Study Sketches Genetic Portrait of the United States 323andMe Study Sketches Genetic Portrait of the United States 4HITLAB Completes GCP Audit for FDA Smart Device & App Compliance 2Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 2Global Facial Recognition Market 2015-2019: Key Vendors are 3M Cogent, Cognitec Systems, NEC and Safran Group 3
... can sustain increasing world-wide demand for at least a ... most important restrictions on future copper production. Researchers ... robust compilation and analysis of worldwide copper resources to ... important metal would run out in around 30 years, ...
... potential new antibiotic which could help in the battle ... antibiotic targets a bacterial enzyme critical to metabolic processes. ... to the enzyme (called biotin protein ligase), stopping its ... "Existing antibiotics target the bacterial cell membranes but ...
... bacteria that form the base of the ocean,s food ... new study. In climate change, as in everything, ... levels and temperature rise globally, scientists increasingly want to ... in the environment of tomorrow. The answer to ...
Cached Biology News:After millennia of mining, copper nowhere near 'peak' 2Novel chemistry for new class of antibiotic 2Greenhouse gas likely altering ocean foodchain 2