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Archive for month: October, 2016

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Updated SME user guide now available

“The European Medicines Agency (EMA) has updated its user guide for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector.”

The full story can be found at www.ema.europe.eu/news_and_events

Source:  www.ema.europe.eu

Samarind RMS is always up to date with the latest regulatory guidelines, if you are a SME and want a solution for getting your pharmaceutical or medical device products to market contact us for a demonstration so we can show you a solution to your problems!

 

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ICH E11(R1) draft Guideline reaches Step 2b of the ICH Process

“The ICH E11(R1) draft Addendum Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 2b of the ICH Process in October 2016 and now enters the consultation period (Step 3). 

This Addendum is proposed to address new scientific and technical knowledge advances in pediatric drug development.”

 

The ICH E11 guideline, created in 2000, is progressing in its process of revision, the original scope of the guideline is unchanged but will now take on board the needed clarification regarding paediatric drug development. The addendum applies to

  • Section 2 on ETHICAL CONSIDERATIONS,
  • Section 4 on AGE CLASSIFICATION AND PEDIATRIC SUBGROUPS INCLUDING NEONATES,
  • Section 7 on PEDIATRIC FORMULATIONS,
  • Section 3 on COMMONALITY OF SCIENTIFIC APPROACH FOR PEDIATRIC DRUG DEVELOPMENT PROGRAMS
  • Section 5 on APPROACHES TO OPTIMIZE PEDIATRIC DRUG DEVELOPMENT

 

For full information please follow the link to the E11 (R1) ICH harmonised guideline http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E11/ICH_E11_R1_Step_2_25Aug2016_Final.pdf

 

Source: http://www.ich.org/ichnews/newsroom/read/article/ich-e11r1-draft-guideline-reaches-step-2b-of-the-ich-process.html

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