Webinar 1

Overview of the Chinese regulatory authorities

& their roles and duties
 Date tbd    60 min    Agenda  
Webinar:
Overview of the Chinese regulatory authorities
  • Chinese regulatory authorities (State Administration for Market Regulation (SAMR), National Medical Products Administration (NMPA), Center of Drug Evaluation (CDE), National Institution of Food and Drug Control (NIFDC), etc.) introduction, their change history, roles and main responsibilities
  • Important regulation/policy reform highlights
 Price: € 150,-
Webinar 2

Clinical trial application (CTA)

in China
 Date tbd    60 min    Agenda  
Webinar:
Clinical trial application (CTA) in China
  • CTA process in China, including the start-up procedures: Ethical Committee (EC) application, human subject samples importation application
  • CTA dossier preparation highlights
  • CMC requirements
  • Change management during CTA
  • Foreign clinical trial data acceptability
  • CTA 'Silent approval' database
  • Clinical trial registry
 Price: € 150,-
Webinar 3

Marketing authorization application (MAA)

in China
 Date tbd    60 min    Agenda  
Webinar:
Marketing authorization application (MAA) in China
  • MAA pathways overview, including the fast MAA approval
  • MAA dossier preparation highlights, CMC requirements
  • Master file bundling review: Requirements for the Application Data of API, excipients and packaging materials
  • Marketing authorization holder system, overseas inspection overview
 Price: € 150,-
Webinar 4

CMC requirements and sample testing

 Date tbd    60 min    Agenda  
Webinar:
CMC requirements and sample testing
  • CMC requirements important highlights during IND and MAA stage
  • Testing strategies during IND and MAA for chemical and biological products
  • Testing procedures and requirements
  • Documents, material preparation, interaction with testing agency, such as National Institution of Food and Drug Control (NIFDC)
 Price: € 150,-