spacer
home > ict > spring 2018 > perfecting performance
PUBLICATIONS
International Clinical Trials

Perfecting Performance

The integration of the new ICH E6 (R2) guideline has created many contradictory opinions about what is necessary to be implemented as sponsor oversight in clinical trials to fulfil its requirements. Of course, sponsor oversight in general is not new, but the details to perform mandatory oversight activities and manage compliance for all clinical trial activities are still raising discussions with different opinions and solutions.

Smaller sponsor, biopharmaceutical, and medical device companies moving into early phase clinical trials are especially struggling with the definition and integration of effective study oversight to manage the quality of their research.

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
Gabriele Faist has more than 28 years' pharma industry experience, with 25 years working in CROs. At the CRO, she was responsible for overseeing clinical drug development programmes, which included line management of a group made up of more than 20, including Project Leaders, Senior Project Leaders, and even Project Assistants, as well as project-related leadership of worldwide multi-functional teams to effectively implement projects, tracking the programme progress to ensure that they are being completed on time and within budget, and maintaining the quality of all work within them.

Heike Schön has more than 25 years of experience in leadership positions in international clinical research and drug development in CROs and biotechnology companies. She has a profound knowledge of clinical drug development processes and regulatory requirements from first-in-human trials to market access. As General Manager, she gained experience in leading and developing a CRO and has successfully implemented her own company, LUMIS International, as Co-Founder and Managing Director. One of her main activities is to support small biotech companies in setting up their clinical
spacer
Gabriele Faist
spacer
spacer
spacer
Heike Schön
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

WuXi STA and Dizal Pharmaceutical Sign CMC Development and Manufacturing Agreement

STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – and Dizal Pharmaceutical, a biotechnology company, announce a strategic partnership. Under the terms of the collaboration, WuXi STA will become the preferred CDMO partner of Dizal Pharmaceutical for GMP production, providing integrated CMC (Chemical, manufacturing and Control) process research and manufacturing services from API to drug product.
More info >>

White Papers

Syringe siliconization

Gerresheimer AG

Ready-to-fill, i.e. sterile, prefillable glass syringes, are washed, siliconized, sterilized and packaged by the primary packaging manufacturer. They can then be filled by the pharmaceutical companies without any further processing. These days the majority of prefillable syringes are made of glass and the trend looks set to continue. The siliconization of the syringe barrel is an extremely important aspect of the production of sterile, prefillable glass syringes because the functional interaction of the glass barrel siliconization and the plunger stopper siliconization is crucial to the efficiency of the entire system. Both inadequate and excessive siliconization can cause problems in this connection. The use of modern technology can achieve an extremely uniform distribution of silicone oil in glass syringes with reduced quantities of silicone oil. Another option for minimizing the amount of free silicone oil in a syringe is the thermal fixation of the silicone oil on the glass surface in a process called baked-on siliconization. Plastic-based silicone oil-free or low-silicone oil prefillable syringe systems are a relatively new development. Silicone oil-free lubricant coatings for syringes are also currently in the development phase.
More info >>

 
Industry Events

SAPHEX 2019

23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA

SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention Centre, Johannesburg, South Africa.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement