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:12/7/2016)... ANN ARBOR, Mich. , Dec. 7, 2016 ... breakthrough immune modulatory medicines, announced today the initiation of ... therapeutic candidate, LYC-30937- E nteric C oated, in ... disease that is estimated to affect as many as ... , with approximately 1.5 - 3 million cases being ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... for SmartBiome -- a novel metagenomic deep-sequencing research platform. SmartBiome combines the ... of hundreds of different genes. The selective early access program is open ...
(Date:12/6/2016)... ... December 06, 2016 , ... The ... asking the Federal Drug Administration (FDA) to consider OA as a serious disease. ... concerned about the growing population of OA patients, many of whom may experience ...
(Date:12/6/2016)... , December 6, 2016 According to a ... Microneedle), Material (Polymer, Glass, Silicon), Application (Genomics, Proteomics, Capillary Electrophoresis, POC, ... MarketsandMarkets, the global market is projected to reach USD 8.78 Billion ... of 19.2% during the forecast period (2016 to 2021). ... ...
Breaking Biology Technology:
(Date:12/5/2016)... 2016  The Office of Justice Programs, National ... Scans Enhance or Replace Medico Legal Autopsies?" on ... or replacing forensic autopsies with postmortem X-ray computed ... In response to recommendations made by The National ... scans as a potential component of medicolegal death ...
(Date:11/29/2016)... , Nov. 29, 2016 BioDirection, a privately ... products for the objective detection of concussion and other ... has successfully completed a meeting with the U.S. Food ... blood test Pre-Submission Package. During the meeting company representatives ... as a precursor to commencement of a planned pilot ...
(Date:11/22/2016)... According to the new market research report "Biometric ... Signature, Voice), Multi-Factor), Component (Hardware and Software), Function (Contact and Non-contact), Application, ... is expected to grow from USD 10.74 Billion in 2015 to reach ... and 2022. Continue Reading ... ...
Breaking Biology News(10 mins):