Regulatory Training on ICH Quality Guidelines
Regulatory Training on ICH Quality Guidelines
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 |