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Regulatory Training on ICH Quality Guidelines

Background and objectives

The Saudi Food and Drug Authority (SFDA) is convening a virtual training program, funded with ICH Regulatory Training Funding, which is specifically designed for quality assessors to acquire in-depth knowledge in Chemistry, Manufacturing and Control (CMC) aspects. The training is consisted of 5 modules throughout 4 weeks from 1 May till 23 May 2023, provided by subject-matter experts. This program aims to assure that the quality assessors understand the philosophy, principles, and practices of the ICH Quality (CMC) guidelines associated with Module 3 of the ICH Common Technical Document (Drug Substance and Drug Product) for Small Molecule and Biological Pharmaceutical Products.

Delivery method and registration

The training will be provided virtually through Zoom platform. A customized link for each module will be sent through email.

Participants from SFDA can register to attend the full program or partially by attending specific module(s).



For more information, please contact:

Standards Department-Drug Sector Drug.Comments@sfda.gov.sa

Module 1: Introductory session



Opening of training program (SFDA)
Monday, 1 May 2023 ( 12:45 PM – 4.15 PM GMT+3 )
Topics: Overview of ICH quality guideline
Speaker: Nadine Ritter & Mark Powell

Module 2: Manufacturing Process of biologics



Tuesday, 2 May 2023 ( 12:45 PM – 4.15 PM GMT+3 )
Topics: Viral safety and characterization of biologics
Speaker: Margit Holzer
Wednesday, 3 May 2023 ( 12:45 PM – 4.15 PM GMT+3 )
Topics: Comparability and GMP of biologics
Speaker: Margit Holzer
Thursday, 4 May 2023 ( 12:45 PM – 4.15 PM GMT+3 )
Topics: Development & manufacture of biologics
Speaker: Margit Holzer
Monday, 8 May 2023 ( 12:45 PM – 4.15 PM GMT+3 )
Topics: Risk management, quality system, and continuous manufacturing of biologics
Speaker: Margit Holzer

Module 3: Analytical aspects for biologics



Tuesday, 9 May 2023 ( 12:45 PM – 4.15 PM GMT+3 )
Topics: Comparability, stability, and analytical validation for Biologics
Speaker: Nadine Ritter
Wednesday, 10 May 2023 ( 12:45 PM – 4.15 PM GMT+3 )
Topics: Impurities, pharmacopeial method, and specifications for Biologics
Speaker: Nadine Ritter
Thursday, 11 May 2023 ( 12:45 PM – 4.15 PM GMT+3 )
Topics: GMP, analytical method development, biosimilarity for Biologics
Speaker: Nadine Ritter

Module 4: Manufacturing process and analytical aspects for small molecules



Monday, 15 May 2023 ( 12:45 PM – 4.15 PM GMT+3 )
Topics: Stability of small molecules
Speaker: Mark Powell
Tuesday, 16 May 2023 ( 12:45 PM – 4.15 PM GMT+3 )
Topics: Method validation and life cycle management of small molecules
Speaker: Mark Powell
Wednesday, 17 May 2023 ( 12:45 PM – 4.15 PM GMT+3 )
Topics: Specifications and bioequivalence of small molecules
Speaker: Mark Powell
Thursday, 18 May 2023 ( 12:45 PM – 4.15 PM GMT+3 )
Topics: Impurities of small molecules
Speaker: Mark Powell

Module 5: Case studies on analytical aspects for small and large molecules



Monday, 22 May 2023 ( 12:45 PM – 4.30 PM GMT+3 )
Topics: Impurities in new drug substances
Speaker: Saleh Alnabhan & Hissah Alrashed, SFDA
Tuesday, 23 May 2023 ( 12:45 PM – 4.30 PM GMT+3 )
Topics: Analytical method development and specifications for biologics
Speaker: Haya S. Alanazi & Amal M. Alsubaie, SFDA

Registration

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