Future events
Process Scale-up, Validation & Technology Transfer
8. December 2025
This online training is focused on QbD-implemented Process Scale-up, Technology Transfer and PV for solid dosage forms.
Design Control and Risk Management For Combination Products
3. February 2026
This online training focuses on how to navigate regulatory expectations for drug-device combinations.
CMC and Regulatory Requirements for Inhalation Drug Products
24. February 2026
Implement ISO 14971 requirements in medical device risk management.
AI Systems in Quality & Regulatory Affairs
24. February 2026
Discover how AI is transforming Quality and Regulatory Affairs. Apply AI to regulatory intelligence, submissions, QMS, and auditing while meeting FDA, EU, and ISO 42001 requirements.
Extractables & Leachables Control Strategies
2. March 2026
Gain practical skills in extractables and leachables risk assessment, study design, and regulatory compliance in this expert-led training.
Process Scale-up & Tech Transfer for Injectables
9. March 2026
This online training is a deep dive into QbD-implemented Process Scale-up, Technology Transfer and PV for sterile injectables.
GMP Investigations and Problem Solving
16. March 2026
The training provides a structured overview of GMP Investigations and Problem Solving to overcome the problems in QA/QC.
CMC Statistics
16. March 2026
CMC Statistics training for pharma professionals — apply key statistical tools for validation, methods, and regulatory success. Accelerate approvals and avoid rejections.
Aseptic Fill-Finish Excellence: Annex 1 Compliance and First Air Protection through Airflow Visualization and CFD Insights
23. March 2026
Learn to develop, qualify, and troubleshoot VHP bio-decontamination cycles in line with Annex 1, ICH Q9(R1), and GMP expectations.
Drug-Device Combination Products: Notified Body Opinion Process
24. March 2026
Combination Products: Notified Body Opinion Process. Gain a comprehensive overview of the application and review process.
CMC/Regulatory Affairs for Nucleic Acids
25. March 2026
This 3-day online course provides a deep dive into the critical aspects of CMC and Regulatory Affairs of nucleic acids.
PK and ADA Assays for Biologics
20. April 2026
Master bioassay development and validation with expert-led training. Gain the tools to ensure precision, and regulatory success.
CMC Regulatory Compliance for Biologics – A CMC approach to IMPD Walkthrough for Biologics
29. April 2026
This training is focused on CMC Regulatory Compliance for Biologics.
Analytical Method Development and Validation
11. May 2026
Learn how to apply ICH Q14, Q2(R2), and USP to develop, validate, and manage analytical methods across their lifecycle.
Development and Validation of Bioassays
8. June 2026
Master bioassay development and validation with expert-led training. Gain the tools to ensure precision, and regulatory success.
Past events
CMO Contracting, Oversight and Value Optimisation
2. December 2025
Master CMO contracting, oversight, and value optimisation, learning practical tools, KPI development and governance models.
CMC for Antibody-Drug Conjugates: Strategies for Successful Development and Manufacturing
1. December 2025
Implement ISO 14971 requirements in medical device risk management.
Mastering Projects and Regulatory Milestones in Generic Drug Development
Gain necessary skills to successfully manage a project in generic pharmaceuticals.
Commercial Functions for CDMOs
Explore the vital role of Sales and other Commercial Functions in today’s heavily fragmented and fiercely competitive CDMO market.
Contamination Control Strategy
This training covers a systematic evaluation of the requirements of the Contamination Control Strategy as detailed in the EU Annex 1 Manufacture of Sterile Medicinal Products.
Process Development of Solid Dosage Formulations
This 2-day training course will focus on the challenges of solid dosage forms development establishing an effective drug development program.
Bioequivalence and IVIVC
Unique online training focusing on bioequivalence, IVIVC, biowaiver guidelines and bioavailability.
Process Scale-up, Validation and Technology Transfer for Biologics
This online training is a deep dive into the world of state-of-the-art process scale-up and technology transfer of biologics.
Lipid Based Formulations
Explore the principles behind lipid-based formulations and delve into topics such as modified and targeted release mechanisms.
Statistics for Non-Statisticians
Learn practical statistics for quality, manufacturing, and R&D with hands-on training in DOE, ANOVA, regression, and process capability.
Advanced Strategies and Future Trends in GMP Auditing
Enhance GMP auditing skills with real-world case studies, global compliance insights, and quality & improvement workshops.
Aseptic Processing in Manufacture of Sterile Products and ATMPs
Master aseptic processing compliance in this expert-led training. Boost your GMP skills for sterile and ATMP manufacturing.
VHP/vH2O2 Bio-Decontamination Master Class
Learn to develop, qualify, and troubleshoot VHP bio-decontamination cycles in line with Annex 1, ICH Q9(R1), and GMP expectations.
GCP & Data Integrity for Analytical Laboratories – ICH E6 R3 in Practice
This training covers the application of ICH E6R3 to analytical labs with GCP expectations for audits and sponsors.
Biometrics in Clinical Trials
Overview of Biometrics in Clinical Trials, focusing on data management, statistical programming, and the use of eClinical systems.
Drug-Device Combination Products: Quality & Regulatory Requirements
This online training focuses on how to navigate regulatory expectations for drug-device combinations.
Storytelling and Thought Leadership: Tactics for CDMO Marketing
Enhance your CDMO marketing skills. Learn about storytelling, thought leadership, customer engagement, and branding.
CMC Module in Regulatory Submissions
Interactive training covering CMC Module in Regulatory Submissions. Gain the tools to ensure potency and regulatory success.
CMC Regulatory Requirements for Biosimilars
3-days of online training with Dr. Len Pattenden on CMC-compliant regulatory practices and quality assurance for Biosimilars.
Stability Testing for Biologics
Equipment Lifecycle Management
Dissolution Testing and Biowaivers
Human Factors for Combination Products
Understand and apply user-centered design principles to the development of combination products.
Technology Transfer for Pharma & Biotech
In-house Training
Specifications for Small Molecule Drug Products
Strategic Marketing for CDMO Industry
CMC Regulatory Compliance for ATMPs
3-days of online training with Dr. Len Pattenden on CMC-compliant regulatory practices for ATMPs.
Advancing Real-World Evidence Generation for Causal Inference
Mitigating Immunogenicity Risk
Annex 1 Compliance: Challenges, Solutions and International Impact (EU GMP & PIC/S)
Quality Requirements for Solids
Stability Testing of Biological Drug Products
Pricing and Market Access of ATMPs
Statistical Methods Across the Product/ Process Lifecycle
Development of Solid Generic Formulations
Clinical Investigations and Evaluation for Medical Devices
Covering clinical evaluation process including regulatory requirements, the principles of clinical evaluation and study design.
Pharma & Biotech Stability Testing
Good Manufacturing Practices in API Production: How to Implement ICHQ7
Paediatric Drug Development & Clinical Trials
This training focuses on paediatric clinical trial guidelines, challenges, patient recruitment and ethical issues.
Mastery in mRNA Manufacturing: Navigating International Regulations & Best Practices
Cleaning Validation in Pharma
Quality Requirements for Biologics
Real-World Evidence in Rare Diseases: Accelerating Market Access
Development of Generic Solid Immediate Release Dosage Forms / Formulation and Analytical Method Development
Dissolution Testing, Equipment Requirements, Quality Control & Biowaivers
Value Added Medicines / Scientific, Regulatory and IP Analysis
Advanced Industrial Process and Unit Operations Scale-up
This course will address critical success factors for process innovation and scale-up from idea to commercial scale start-up.
Orphan Drugs Clinical Trials
Join this training and explore orphan drugs regulatory guidance and clinical trials strategies with former EMA professional Dr. Simon Day.
Pharmaceutical Quality: QRM, CAPA & Root Cause Analysis
Process Scale-up, Validation and Technology Transfer for Medical Devices
This training is a deep dive into Process Scale-up, Tech Transfer and PV for medical devices.