spacer
home > pmps > autumn 2013 >
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer


Rate this article You must be a member of the site to make a vote.  
Average rating:
1
     

There are no comments in regards to this article.

spacer
News and Press Releases

Destiny Pharma appoints MedPharm to develop new XF-platform drug formulations

Destiny Pharma, a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, is pleased to announce that it has appointed MedPharm as its expert partner to develop new topical formulations of the Companys novel XF-platform compounds. These new treatments for dermal and ocular infections are part of its second clinical programme to address the global problem of anti-microbial resistance (AMR). MedPharm is a world leading contract provider of topical and transdermal product design and formulation development services using sophisticated in vitro models to de-risk development programmes.
More info >>

White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
More info >>

 
Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement