spacer
home > epc > Autumn 2016
PUBLICATIONS

European Pharmaceutical Contractor

epc
Autumn 2016

   
Text
PDF
bullet
Legal & Regulatory
ICH E6 (R2) Addendum

Game Changer


The new ICH guidance will be implemented in November 2016, which will have a profound effect on the management of clinical trials. Nick Neri at ERT outlines some of the steps that pharma companies need to take in order to remain compliant.
 
view
download pdf
Data De-Identification

Protecting Patient Identities


As organisations are required to become more transparent in their studies, the identities of patients are being put at risk. d-Wise’s Chris Olinger comments on new guidelines trying to alleviate this problem.
 
view
download pdf
Spotlight

The Path to Easier Product Lifecycle Maintenance

TRAC Services
reveals the importance of the regulatory affairs function within pharma, and how good document management is critical in the successful production of drugs.
 
view
download pdf
Regulatory Update

On Duty

Viktoriya Angelova
at Rephine gives an overview of the most significant changes the new ICH Addendum brings, particularly with regards to sponsor and investigator responsibilities.


 
view
download pdf
bullet
Reviews & Previews
Event Review

Up to Standard?


A central theme of this year’s DIA annual meeting in Philadelphia, US, was cyber identity and the issues associated with it. Jon Weisberg at SAFE-BioPharma reports.
 
view
download pdf
bullet
Data Management & IT Solutions
Biostatistics

SAS and R Team in Clinical Research


To either prove or disprove stated hypotheses, it is necessary to carry out statistical analyses and collect data. KCR’s Adrian Olszewski introduces two reliable packages to support evidencebased research on drugs.


 
view
download pdf
   
spacer



Published quarterly in
February, May,
August, and November

News and Press Releases

Smart Bioprocessing with the new Eppendorf Control System

Hamburg, February 12, 2020 Working with flexible systems that evolve with the changing needs in a lab is indispensable. With the SciVario twin, Eppendorf, a key life science company, introduces its latest bioreactor control system for small- and bench-scale applications. The intelligent controller and new, innovative bay-drawer system enables the exchange of standardized modules to flexibly adapt the controller to the changing requirements in a laboratory.
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

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement