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ANNEX 1
Design Control and Risk Management For Combination Products
1. October 2024
Contamination Control Strategy
2. October 2024
CMC Regulatory Compliance for Biological Drug Products
2. October 2024
Process Scale-up, Validation and Technology Transfer for Biologics
14. October 2024
Development and Validation of Bioassays
14. October 2024
Mastery in mRNA Manufacturing: Navigating International Regulations & Best Practices
15. October 2024
Medical Device Risk Management: Understand and Interpret Key Regulations and Standards
15. October 2024
Project Management for Generics
21. October 2024
Extractables and Leachables Control Strategies
22. October 2024
Paediatric Drug Development & Clinical Trials
24. October 2024
Aseptic Processing in Manufacture of Sterile Products & ATMPs
28. October 2024
Lipid Based Formulations
28. October 2024
Process Scale-up, Validation & Technology Transfer
28. October 2024
CMC Statistics
4. November 2024
Aseptic Fill & Finish of Biologics
9. December 2024
Drug-Device Combination Products: Quality & Regulatory Requirements
10. December 2024
Bioequivalence and IVIVC
11. December 2024
CMO Contracting, Oversight and Value Optimisation
10. February 2025
CMC and Regulatory Requirements for Inhalation Drug Products
11. February 2025
Development and Validation of Bioassays
10. March 2025
Process Scale-up & Tech Transfer for Injectables
10. March 2025
Cleaning Validation in Pharma
CMC Regulatory Compliance for ATMPs
Annex 1 Compliance: Challenges, Solutions and International Impact (EU GMP & PIC/S)
GMP Lead Auditor
Technology Transfer for Pharma & Biotech
Clinical Investigations and Evaluation for Medical Devices
CMC/Regulatory Affairs for Nucleic Acids
Human Factors for Combination Products
Drug-Device Combination Products: Notified Body Opinion Process
Orphan Drugs Clinical Trials
Clinical Trial Design & Quality
Process Scale-up, Validation and Technology Transfer for Medical Devices
Development of Solid Generic Formulations
Strategic Marketing for CDMO Industry
Quality Requirements for Solids
Analytical Method Development and Validation
Pharma & Biotech Stability Testing
Pricing and Market Access of ATMPs
Value Added Medicines / Scientific, Regulatory and IP Analysis
Statistical Methods Across the Product/ Process Lifecycle
Specifications for Small Molecule Drug Products
Dissolution Testing, Equipment Requirements, Quality Control & Biowaivers
Pharmaceutical Quality: QRM, CAPA & Root Cause Analysis
Development of Generic Solid Immediate Release Dosage Forms / Formulation and Analytical Method Development
Advancing Real-World Evidence Generation for Causal Inference
2. October 2023
Advanced Industrial Process and Unit Operations Scale-up
Real-World Evidence in Rare Diseases: Accelerating Market Access
Pharmaceutical Data Integrity
Change Management for Medical Affairs
Good Manufacturing Practices in API Production: How to Implement ICHQ7
Quality Requirements for Biologics
Mitigating Immunogenicity Risk
Signal Detection and Management in Pharmacovigilance
Contamination Control Strategy
2. October 2024
CMC Regulatory Compliance for Biological Drug Products
2. October 2024
Process Scale-up, Validation and Technology Transfer for Biologics
14. October 2024
Development and Validation of Bioassays
14. October 2024
Mastery in mRNA Manufacturing: Navigating International Regulations & Best Practices
15. October 2024
Project Management for Generics
21. October 2024
Extractables and Leachables Control Strategies
22. October 2024
Paediatric Drug Development & Clinical Trials
24. October 2024
Aseptic Processing in Manufacture of Sterile Products & ATMPs
28. October 2024
Lipid Based Formulations
28. October 2024
Process Scale-up, Validation & Technology Transfer
28. October 2024
CMC Statistics
4. November 2024
Aseptic Fill & Finish of Biologics
9. December 2024
Drug-Device Combination Products: Quality & Regulatory Requirements
10. December 2024
Bioequivalence and IVIVC
11. December 2024
CMO Contracting, Oversight and Value Optimisation
10. February 2025
CMC and Regulatory Requirements for Inhalation Drug Products
11. February 2025
Development and Validation of Bioassays
10. March 2025
Process Scale-up & Tech Transfer for Injectables
10. March 2025
Cleaning Validation in Pharma
CMC Regulatory Compliance for ATMPs
Annex 1 Compliance: Challenges, Solutions and International Impact (EU GMP & PIC/S)
GMP Lead Auditor
Technology Transfer for Pharma & Biotech
CMC/Regulatory Affairs for Nucleic Acids
Orphan Drugs Clinical Trials
Clinical Trial Design & Quality
Development of Solid Generic Formulations
Strategic Marketing for CDMO Industry
Quality Requirements for Solids
Analytical Method Development and Validation
Pharma & Biotech Stability Testing
Pricing and Market Access of ATMPs
Value Added Medicines / Scientific, Regulatory and IP Analysis
Statistical Methods Across the Product/ Process Lifecycle
Specifications for Small Molecule Drug Products
Dissolution Testing, Equipment Requirements, Quality Control & Biowaivers
Pharmaceutical Quality: QRM, CAPA & Root Cause Analysis
Development of Generic Solid Immediate Release Dosage Forms / Formulation and Analytical Method Development
Advancing Real-World Evidence Generation for Causal Inference
2. October 2023
Real-World Evidence in Rare Diseases: Accelerating Market Access
Pharmaceutical Data Integrity
Change Management for Medical Affairs
Good Manufacturing Practices in API Production: How to Implement ICHQ7
Quality Requirements for Biologics
Mitigating Immunogenicity Risk
Signal Detection and Management in Pharmacovigilance
Design Control and Risk Management For Combination Products
1. October 2024
Medical Device Risk Management: Understand and Interpret Key Regulations and Standards
15. October 2024
Drug-Device Combination Products: Quality & Regulatory Requirements
10. December 2024
CMC and Regulatory Requirements for Inhalation Drug Products
11. February 2025
Clinical Investigations and Evaluation for Medical Devices
Human Factors for Combination Products
Drug-Device Combination Products: Notified Body Opinion Process
Process Scale-up, Validation and Technology Transfer for Medical Devices
Advanced Industrial Process and Unit Operations Scale-up
Contamination Control Strategy
2. October 2024
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