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:5/6/2015)... TAMPA, Fla. , May 6, 2015  Oxis ... International, Inc. OTC: OXIS, OXI.PA, announced today that ... Oncology, Division of Cancer Medicine at the University of ... board.  Dr. Yee is also Professor, Department of Immunology, ... Therapy, Center for Cancer Immunology Research at the University ...
(Date:5/6/2015)... Dr Jaspreet Singh , Senior Research ... a speech at the 2015 Asian Starch Conference, to be ... Center.  , ... topic: ,Potato Starch: A Potential Source for the Creation ... Co-editor of a 528 page text book entitled "Advances ...
(Date:5/5/2015)... 2015 /PRNewswire/ - Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS) ... the three months ended March 31, 2015 and provided ... in Canadian dollars. Effective July 17, ... May 31 to December 31. As a result of ... for the three months ended March 31, 2015, while ...
(Date:5/5/2015)... Hayden-McNeil is pleased to announce ... materials for smaller courses. This program is specifically designed ... students. , “I’m very excited about offering our ... instructors,” said Jeff McCarthy, Hayden-McNeil president. “By working with ... part to make education both more effective and affordable.” ...
Breaking Biology Technology:Oxis Biotech Appoints Cassian Yee, M.D. To Its Scientific Advisory Board 2Oxis Biotech Appoints Cassian Yee, M.D. To Its Scientific Advisory Board 3Potato Starch: A Potential Source for the Creation of Next Generation Bulk-ingredients and Smart Foods 2Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 2Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 3Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 4Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 5Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 6Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 7Aptose Biosciences Reports Results for the First Quarter Ended March 31, 2015 8Hayden-McNeil Expands Publishing Program to Service Lower Enrollment Courses 2
... National Laboratory (Berkeley Lab) and the University of ... of nanoparticles into device-ready materials. Through a relatively ... with block co-polymer supramolecules, the researchers produced multiple-layers ... and three-dimensional arrays of gold nanoparticles. Thin films ...
...  X-BODY BioSciences, Inc., a developer of monoclonal antibody therapeutics, ... for antibodies against targets on the surface of live ... associated Biologics Partnering Forum being held April 28th through ... Wagner, Ph.D., Co-Founder and Executive Chairman of X-BODY, will ...
... NEW YORK, April 26, 2012 Reportlinker.com announces ... in its catalogue:   ... http://www.reportlinker.com/p0152432/Global-Genetic-Engineering-Industry.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Genetical   ... a collection of market briefs and concise summaries ...
Cached Biology Technology:Golden potential for gold thin films 2Golden potential for gold thin films 3X-BODY BioSciences to Present Novel Methods of Selecting for Antibodies Against Targets on Live Cells at CHI's Protein Engineering Summit 2Global Genetic Engineering Industry 2Global Genetic Engineering Industry 3Global Genetic Engineering Industry 4Global Genetic Engineering Industry 5Global Genetic Engineering Industry 6Global Genetic Engineering Industry 7
(Date:4/6/2015)... Apr. 6, 2015 NXT-ID, Inc. (NASDAQ: ... authentication company focused on the growing mobile commerce ... patent 62/143028 for MINIATURE, MULTI-PURPOSE ANTENNA ... NXT-ID introduces a new revolutionary method ... surrounds the use of miniature antenna modules for ...
(Date:4/2/2015)... , April 2, 2015 At its ... Salt Lake City , the American College of ... five new directors to its Board.  Members of the ... ACMG and for forming and advancing its policies and ... genetics profession. "It,s an eventful time in ...
(Date:4/2/2015)... GOTHENBURG, Sweden , April 2, 2015 ... for its touch fingerprint sensor FPC1025 from the distributor ... Deliveries will commence during Q2 2015 although the major ... 2015. The sensors will be used by smartphone manufacturers ... of 110 MSEK is included in the communicated revenue ...
Breaking Biology News(10 mins):NXT-ID Patents Miniature, Low Power Wireless Magnetic Stripe 2NXT-ID Patents Miniature, Low Power Wireless Magnetic Stripe 3NXT-ID Patents Miniature, Low Power Wireless Magnetic Stripe 4American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 2American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 3American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 4American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 5American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 6American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 7American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 8Fingerprint Cards Receives Touch Fingerprint Sensor Order of SEK 110 Million 2
... at the Virginia Bioinformatics Institute at Virginia Tech and the ... 454 Life Sciences of Branford, Conn., have sequenced the genome ... a naturally occurring strain of B. abortus that ... Buck in 1923. It has been used for more than ...
... The long cherished goal of applying the strange properties ... has been brought closer by a series of recent ... field of quantum optics and discussed recently at a ... in collaboration with the Fonds zur Frderung der wissenschaftlichen ...
... A Dutch engineer has devised a simple solution to ... the current issue of the International Journal of Global ... solidifying waste in a concrete-type material and using the ... with waste disposal but could become tourist traps and ...
Cached Biology News:Brucella abortus S19 genome sequenced; points toward virulence genes 2Europe gets together to harness quantum physics 2Europe gets together to harness quantum physics 3Europe gets together to harness quantum physics 4Building on pyramids of trash 2