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:8/28/2014)... 2014  Armetheon, Inc. ( www.armetheon.com ), a ... late-stage cardiovascular drug candidates, today announced that it ... of financing. The Series A round was co-led ... participation from investors that included Atheneos Capital and ... Larry Hsu , the founder of Impax Laboratories. ...
(Date:8/28/2014)... 27, 2014 Scientists, researchers, and technologists ... SPIE Laser Damage 2014 symposium. Marking its 46th ... lasers will run 14-17 September. The event is sponsored ... photonics . , The premier conference for basic and ... to optical materials will engage researchers and engineers from ...
(Date:8/28/2014)... Earlier this month, a report ... with the U.S. Air Force on the performance of ... that this type of fuel made from mustard seeds, ... important to America’s Eco friendly future. In fact, every ... to become independent of foreign oil over the next ...
(Date:8/28/2014)... (PRWEB) August 28, 2014 Supplementing ... offering a promotion for Eppendorf Safe Lock ... to purchase the highest quality tubes at an ... ideal for customers doing chemical, medical, pharmaceutical, and ... who are not regularly able to afford Eppendorf ...
Breaking Biology Technology:Armetheon Completes $7.0 Million Series A Financing 2Armetheon Completes $7.0 Million Series A Financing 3Laser Damage to Draw Researchers, Engineers, Scientists to 46th Annual Conference 2Laser Damage to Draw Researchers, Engineers, Scientists to 46th Annual Conference 3Can Small Farmers and a New Seed Based Biofuel “Green” the World? Major Universities and Even the U.S. Air Force Seem to Think So 2Can Small Farmers and a New Seed Based Biofuel “Green” the World? Major Universities and Even the U.S. Air Force Seem to Think So 3Can Small Farmers and a New Seed Based Biofuel “Green” the World? Major Universities and Even the U.S. Air Force Seem to Think So 4Can Small Farmers and a New Seed Based Biofuel “Green” the World? Major Universities and Even the U.S. Air Force Seem to Think So 5Eppendorf Safe Lock Centrifuge Tube Promotion Now Available at Major Pipette Distributor Pipette.com 2Eppendorf Safe Lock Centrifuge Tube Promotion Now Available at Major Pipette Distributor Pipette.com 3
... 16 ARUP Laboratories, a national,clinical and anatomic pathology ... development, announced today that,company co-founder Carl R. Kjeldsberg, MD, ... of June 2009. Kjeldsberg has held the position,since 1993 ... chairman of,the Board., Effective, July 1, 2009, Edward ...
... MEDX ) announced today data from a ... higher doses of MDX-060, an investigational,anti-CD30 antibody, and ... patients with relapsed or refractory CD30-,positive lymphomas. Results ... the,Annual Meeting of the American Association for Cancer ...
... of Hollings Expanded Building, CHARLESTON, S.C., April 16 ... has dedicated the Edwin and Barbara,Pearlstine Healing Garden. The ... $1 million gift from Edwin S. Pearlstine, Jr., in ... who died of cancer in,1997., "Edwin and Barbara ...
Cached Biology Technology:ARUP Laboratories CEO and Co-Founder Announces Retirement 2Medarex Reports Phase 1/2 Clinical Data of MDX-060 in Lymphoma at American Association for Cancer Research Meeting 2Medarex Reports Phase 1/2 Clinical Data of MDX-060 in Lymphoma at American Association for Cancer Research Meeting 3MUSC's Hollings Cancer Center Dedicates Edwin and Barbara Pearlstine Healing Garden Endowed with $1 Million Gift from Edwin S. Pearlstine, Jr. 2
(Date:8/28/2014)... Bethesda, MD FASEB MARC (Maximizing Access to ... recipients for the Genetics Society of America,s 27th ... October 3, 2014 in Pacific Grove, California. ... entry of students, post doctorates and scientists from ... science community and to encourage the participation of ...
(Date:8/28/2014)... A unique method for delivering compounds that ... HIV and AIDS may be possible, thanks ... Agricultural Sciences., A semi-soft vaginal suppository made ... loaded with the antiviral drug Tenofovir provides ... against the spread of sexually transmitted infections ...
(Date:8/28/2014)... 28, 2014 Dyslexia, the most commonly diagnosed ... neurological reading disability that occurs when the regions ... function normally. , The use of non-invasive functional ... is disrupted in dyslexia. However, most prior work ... brain regions, leaving a gap in our understanding ...
Breaking Biology News(10 mins):Sensory-tested drug-delivery vehicle could limit spread of HIV, AIDS 2Sensory-tested drug-delivery vehicle could limit spread of HIV, AIDS 3Dyslexic readers have disrupted network connections in the brain 2
... 45,000 corneal transplant eye surgeries are performed in the ... effort to standardize this complex procedure, two video articles ... JoVE, the Journal of Visualized Experiments . These ... and the United States. By utilizing the JoVE,s ...
... as ,green phones, for communication with other bugs. A ... insects are also able to leave ,voicemail, messages in ... effects on soil fungi. Researchers from the Netherlands Institute ... unique messaging service in the ragwort plant. The influential ...
... non-protein-coding RNAs start off as long strands of ... a special kind of machinery, the "Microprocessor" complex, to ... miRNAs bind to messenger RNA (mRNAs) molecules, inhibiting their ... hundreds of different proteins. But the Microprocessor complex ...
Cached Biology News:Pre-surgical steps for eye surgery are standardized through JoVE's video publication 2Voicemail discovered in nature 2Living microprocessor tunes in to feedback 2
Detects activated caspases in living cells. Simple/sensitive/straight-forward procedure takes only 30 minutes. Results can be analyzed by flow cytometry/fluorescence microscopy/fluorescence plate rea...
Anti-Mouse Qa.m7, Ascites (Clone 5035-50.1) (mouse IgM)...
DAPI: 4', 6-Diamino-2-phenylindole dihydrochloride. Antifade Solution: p-Phenylenediamine and glycerol in PBS solution. 0.4g/mL DAPI suspended in Antifade....
... 13(S)-HODE-d4 contains 4 deuterium atoms at the ... intended for use as an internal standard for ... spectrometry. 13(S)-HODE is produced by incubation of linoleic ... been shown to inhibit the adhesion of tumor ...
Biology Products: