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:2/16/2017)... Feb. 16, 2017 Research and ... Biology: Global Markets" report to their offering. ... ... genes, biobrick parts, delivery plasmids, chassis organisms, synthetic cells, ... assembly, genome editing, bioinformatics and specialty media) and enabled ...
(Date:2/16/2017)... HOLLISTON, Mass. , Feb. 16, 2017   ... or the "Company"), a biotechnology company developing bioengineered organ ... the esophagus, bronchus and trachea, announced today the closing ... offering of 20,000,000 shares of common stock and warrants ... gross proceeds of $8.0 million. The offering was priced ...
(Date:2/16/2017)... , Feb. 16, 2017 UCHealth ( ... utilize LungDirect for pulmonary nodule patient management. In addition ... or a spot on the lung, UCHealth looks to ... manual data entry. Stephanie Brown, RN ... my nodule patients with an Excel spreadsheet, which was ...
(Date:2/16/2017)... 2017  Champions Oncology, Inc. (NASDAQ: CSBR ... of advanced technology solutions and products to personalize the ... addition of new cohorts of PDX models to their ... expand Champions, product line in hepatocellular cancer, breast cancer, ... and non-small cell lung cancer (including EGFR mutation; ALK/ROS1 ...
Breaking Biology Technology:
(Date:1/31/2017)... , Jan. 31, 2017  Spero Therapeutics, ... therapies for the treatment of bacterial infections, today ... of antibacterial candidates from Pro Bono Bio Ltd ... prevalence of multi-drug resistant forms of Gram-negative bacteria.  ... Anti Infectives Ltd, a PBB group company. ...
(Date:1/26/2017)... 2017  Crossmatch, a leading provider of security and ... at combatting fraud, waste and abuse in assistance operations ... Action on Disaster Relief conference in Panama ... agencies and foreign assistance organizations throughout Latin ... are a largely unacknowledged problem in the foreign assistance ...
(Date:1/25/2017)... , Jan. 25, 2017 The Elements of ... (IAM) lifecycle is comprised of a comprehensive set ... purpose of maintaining digital identities and providing a ... applications. There are significant number of programs opted ... to time by optimizing processes and changing policies. ...
Breaking Biology News(10 mins):