samedan logo

 
 
spacer
home > ict > summer 2019 > then and now
PUBLICATIONS
International Clinical Trials

Then and Now





As I write, the world is celebrating the 50th anniversary of the first human landing on the moon. Letís look back at some of the things that were in effect back then. The EU was the EEC, just six countries, but the Council Directive 65/65/EEC had been introduced in the wake of the thalidomide disaster. This was about detailed marketing authorisation requirements across the European community. It took another five years, until 1970, for the directive to be incorporated into the national laws of each member state of the then EEC. There was no clinical trials directive, so there was no real legislative control on clinical trials, although the Helsinki Declaration had been set in 1964 to avoid unethical and unsafe clinical trials and for safe and proper treatment of human subjects.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Dr Graham Hughes
ICT Editor
Print this page
Send to a friend
Privacy statement
News and Press Releases

CPI to showcase results from BioStreamline project developing novel biotherapeutics

CPI, a UK-based technology innovation centre and a founding member of the High Value Manufacturing Catapult, announced today that it will host an event in Darlington, UK on 26 June 2019 to disseminate the results of the £11.2M BioStreamline project to optimise the development of novel therapeutics. During the event, the project partners ó Lonza Biologics, UCB Celltech, Sphere Fluidics, Horizon Discovery Group plc (Horizon), Alcyomics Ltd and CPI ó will showcase the results and discuss the potential impact on overcoming some of the most significant shortcomings of the biologics supply chain.
More info >>

White Papers

Assessing the Integrity of Pharmaceutical Packaging Using the Sepha Blisterscan and Conventional Blue Dye Leak Testing Methods

Sepha Limited

A new whitepaper by a leading packaging expert from the University of Ulster, Dr Dorian Dixon, into the integrity of pharmaceutical packaging has established that existing methods for testing the seal integrity of blister packs are not as accurate as newer, technology based test equipment.
More info >>

 
Industry Events

Clinical Operations in Oncology Trials West Coast

21-22 April 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement