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. Let’s 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

High throughput, low energy consumption: AVENTUS to showcase high-performance packaging systems at interpack

• Joint venture for a broad range of solutions • Powerful and low-maintenance units for free-flowing bulk materials • Solutions for agriculture as well as the chemicals, salts, fertilisers pet food and animal feed industries
More info >>

White Papers

Life Cycle of an Analytical Method - a Case Study on the Monocyte Activation Test

Wickham Laboratories Limited

Pyrogens, a heterogeneous group of fever inducing contaminants, are comprised of microbial and non-microbial compounds; e.g. endotoxin (lipopolysaccharide, LPS) produced by Gram-negative bacteria, lipoteichoic acid (LTA) from Gram-positive bacteria, bacterial DNA (CpG-motive), endogenous pyrogens, virus and fungi particles or even fragments of packaging materials, plastic and dust. Contaminat ion wi th pyrogens in pharmaceutical products, biotherapeutics and on medical devices can lead to life threatening fever reactions. To ensure consumer safety, pyrogen testing is mandatory for parenteral products and medical devices.
More info >>

 
Industry Events

Formulation and Drug Delivery Series UK

8-9 July 2020, Oxford Global

This event brings together leading formulation, drug delivery and biologics manufacturing experts from around the world across two days. The panel of prominent industry leaders and world-leading scientists will share the latest case studies, innovative developments for novel therapeutic products and strategies for drug development.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement