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:9/15/2014)... interdisciplinary team of researchers led by Northeastern University ... precise inter-nanotube junctions and a variety of nanocarbon ... facile and easily scalable, which will allow the ... networks for use in applications ranging from electronic ... from cars to sports equipment. , Their findings ...
(Date:9/15/2014)... , Sept. 15, 2014  iVinci Health LLC, the ... Patient Revenue Management system, branded as VisitPay®, has successfully ... announced the launch of a new extension to VisitPay® ... an easy and convenient way for patients to manage ... owed by them and their families. The ...
(Date:9/15/2014)... CA (PRWEB) September 15, 2014 ... term implantable silicones for the medical device and ... silicone gel for the implantable medical device market. ... unique crosslink technology delivering a silicone gel with ... The Dual Matrix technology consists of two crosslinked ...
(Date:9/15/2014)... septiembre de 2014 La segunda anual International ... 12 al 18 de octubre. Como iniciativa conjunta de la ... compañías miembro s, la IPAW se ha diseñado para: ... a la colección de fuentes de plasma , Reconocimiento ... y mejorar las vidas , Aumento del conocimiento sobre ...
Breaking Biology Technology:Northeastern University Researchers Develop Novel Method for Working with Nanotubes 2iVinci Health Raises $5M to Fuel National Expansion, Announces Launch of Personal Finance Portal for Healthcare 2iVinci Health Raises $5M to Fuel National Expansion, Announces Launch of Personal Finance Portal for Healthcare 3Applied Silicone Launches Silicone Gel System with Dual Matrix Technology 2La International Plasma Awareness Week será una celebración para los donantes 2La International Plasma Awareness Week será una celebración para los donantes 3
... 2008 at 9:00 a.m. Eastern ... ... ALSE ) today reports operational and,financial results for the quarter ended ... http://www.newscom.com/cgi-bin/prnh/20080813/NEW056LOGO ), "We are encouraged by the progress we ...
... Named Contract Manufacturer of Choice, Based on Its ... Based on its recent,analysis of the pharmaceutical ... BioPharma Solutions (BPS) with the 2008 North,American Frost ... Award at,the 2008 Excellence in Healthcare Innovation Awards ...
... Novavax uses strategies to create vaccines for avian flu ... genetically-engineered virus-like particles (VLPs), ROCKVILLE, Md., ... today that its strategy for treating avian flu,through genetically-engineered ... at Cleveland Clinic 6th Annual Medical Innovation,Summit., Novavax, ...
Cached Biology Technology:Alseres Pharmaceuticals, Inc. Reports Third Quarter 2008 Operational and Financial Results 2Alseres Pharmaceuticals, Inc. Reports Third Quarter 2008 Operational and Financial Results 3Alseres Pharmaceuticals, Inc. Reports Third Quarter 2008 Operational and Financial Results 4Alseres Pharmaceuticals, Inc. Reports Third Quarter 2008 Operational and Financial Results 5Frost & Sullivan Awards Baxter's BioPharma Solutions Business the 2008 North American Customer Service Leadership of the Year Award 2Frost & Sullivan Awards Baxter's BioPharma Solutions Business the 2008 North American Customer Service Leadership of the Year Award 3Cleveland Clinic Recognizes New Strategies for Creating Vaccines for Avian Flu as a Top Ten Medical Innovation for 2009 2Cleveland Clinic Recognizes New Strategies for Creating Vaccines for Avian Flu as a Top Ten Medical Innovation for 2009 3Cleveland Clinic Recognizes New Strategies for Creating Vaccines for Avian Flu as a Top Ten Medical Innovation for 2009 4
(Date:9/15/2014)... need for vitamin E and how much is enough, ... of this essential micronutrient are especially critical for the ... may become pregnant. , A lifelong proper intake of ... complicated by the fact that this nutrient is one ... It has been estimated that only a tiny fraction ...
(Date:9/12/2014)... , September 12, 2014 ... http://www.researchandmarkets.com/research/trs4c7/global ) has announced the addition of ... 2014" report to their offering. ,     ... Report 2014 is a professional and in-depth ... global fingerprint lock industry. , ,The report ...
(Date:9/12/2014)... of New York biologist Mike Hickerson, a team of international ... so many species of birds ended up in the Neotropics, ... the southernmost tip of South America. It is home to ... has beenhow did this extraordinary bird diversity originate?" said Dr. ... published in the journal Nature this week and ...
Breaking Biology News(10 mins):Vitamin E intake critical during 'the first 1,000 days' 2Vitamin E intake critical during 'the first 1,000 days' 3Global Fingerprint Lock Industry Report 2014 2
... of Biologists is pleased to announce BIOLOGY OPEN (BiO), ... research across all aspects of the biological sciences including ... journal aims to provide rapid publication for peer reviewed, ... fields. BIOLOGY OPEN will address some big issues ...
... a big effect on their life. Some people are ... which can be detrimental to their health and wellbeing. ... , A new study led by Dr Kathryn ... York has added important experimental evidence showing that animal ...
... fish, one from a Caribbean island and one from the Yucatan ... known in any organism, according to a new UC Davis study. ... Venezuela -- and they are all pretty much the same, said ... with Peter Wainwright, a professor of evolution and ecology at UC ...
Cached Biology News:Announcing BIOLOGY OPEN from the Company of Biologists 2Animals have personalities, too 2'Explosive' evolution in pupfish 2
... Single Cell Whole Genome Amplification Kit ... random fragmentation of genomic DNA and ... to PCR-amplifiable library molecules flanked by ... by PCR amplification of the library ...
Mouse monoclonal antibody to QARS - glutaminyl-tRNA synthetase...
Rabbit Anti-Mouse Ym1 Polyclonal Antibody,...
From formula-fed bovine calves Sterile, Cell culture tested...
Biology Products: