samedan logo
 
 
spacer
home > events calendar
PHARMACEUTICAL INDUSTRY EVENTS CALENDAR
   
  
EVENTS FOR 2019
   
 
EVENTS FOR PMPS
 
     


There is currently no events listed for this month. Please check all events or come back soon as it is updated regularly.

spacer
Industry Events

INTERPHEX 2019

2-4 April 2019, Javits Center, New York

At INTERPHEX, find all of the State-of-the-Art Solutions you need to Cost Effectively Develop and Manufacture Product. INTERPHEX is a premier pharmaceutical, biotechnology, and medical device development and manufacturing event and sponsored by Parenteral Drug Association (PDA). Dedicated to Innovation, Technologies and Knowledge, the show focuses on the entire product development life cycle.
More info >>

Banner of DIA_Europe_Events_95 on Samedan Banner of Drug Delivery Partnership 2018_events_97 on Samedan

White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
More info >>


News and Press Releases

2019 IPEC Europe Annual Excipients Forum, Malta, 31 January

Join NSF at this dynamic conference in Malta on the 31st January 2019, recognised to be one of the key events for pharmaceutical excipients in Europe.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement