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Updates on the new ICH quality guidelines: ICH Q13 and Q14

CMC Seminar Duke-NUS
The International Council for Harmonisation (ICH) has recently announced the development of the new Quality guidelines (Q13 and Q14) relating to continuous manufacturing and analytical procedure development respectively.  In addition to guiding the industry and regulatory agencies on the requirements of continuous manufacturing technologies used in the manufacture of pharmaceuticals, these also reflect the key intent to harmonise the scientific approaches of analytical procedure development, through understanding the underlying principles. This seminar provides a valuable opportunity to hear from Dr Moheb who is highly involved in developing these guidelines, as he draws also from his immense experience to share on the impact of the trending movement in the regulation of pharmaceuticals.

HOST: 

Prof John Lim
Executive Director, CoRE
Duke- NUS Medical School
Core Lead (Policy)
Singhealth Duke-NUS Global Health Institute

VENUE: 
Grand Copthorne Waterfront Hotel
OTHER INFORMATION: 

Registration Fee: $70

 

Click here to register.

 

CONTACT PERSON: 

Date and Time


21 Mar 2019 @ 17:30 - 21 Mar 2019 @ 19:30

Speaker


Dr Moheb Nasr
Principal
Nasr Pharma Regulatory Consulting (NPRC)
Former Vice President
CMC Strategy
GlaxoSmithKline

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