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:3/22/2017)... , March 22, 2017   iSpecimen ®, ... announced that Doctors Pathology Service (DPS), a ... of the United States , has ... Delaware Health Information Network (DHIN) to make human ... The novel program, announced in 2015 as ...
(Date:3/22/2017)... March 22, 2017   VWR ... of product and service solutions to laboratory ... has acquired EPL Archives, Inc., an international ... the entire regulated product research, development and ... storage and ancillary services. EPL Archives is ...
(Date:3/22/2017)... ... March 21, 2017 , ... ... more than tripling its goal and raising over $30,000 in the first 40 ... grows nutritious veggies & herbs fast, easy, and affordably, anywhere. , “Simply add ...
(Date:3/22/2017)... Iowa (PRWEB) , ... March 22, 2017 , ... March ... is time for another green revolution, one that utilizes technological innovation in smart, sustainable ... tangible aspects of life such as aesthetics and environmental stability. This paper is the ...
Breaking Biology Technology:
(Date:3/7/2017)... , March 7, 2017   HireVue , the ... global companies identify the best talent, faster, today announced ... Sales Officer (CSO) and Diana Kucer as ... out a seasoned executive team poised to drive continued growth ... on a year of record bookings in 2017. ...
(Date:3/2/2017)... 2, 2017 Australian stem cell and regenerative ... has signed an agreement with the Monash Lung Biology ... Discovery Institute and Department of Pharmacology at Monash University, ... preclinical study to support the use of Cymerus™ mesenchymal ... Asthma is a chronic, long term lung ...
(Date:2/27/2017)... , Feb. 27, 2017   Strategic Cyber Ventures ... it has led a $3.5 million investment in  Polarity ... Strategic Cyber Ventures is DC based and is led ... Hank Thomas . Ron Gula , also a ... also participated in this series A round of funding. ...
Breaking Biology News(10 mins):