Mastering eCTD for Africa’s Evolving Regulatory Landscape
The electronic Common Technical Document (eCTD) has become the global standard for regulatory submissions, streamlining how applications are prepared, validated, and reviewed. As more African regulatory authorities move towards digital submission systems, it is essential for pharmaceutical professionals across the continent to be prepared.
At the AfriSummit eCTD Training, you will gain practical, hands-on expertise in preparing and managing eCTD submissions tailored to the African regulatory environment, while also aligning with international standards.
Why Attend?
- Africa-Focused Training – Understand how eCTD adoption is evolving across the continent, the challenges faced by companies, and practical solutions for successful submissions.
- Hands-On Learning – Work through real-world case studies, role-play exercises, and group activities simulating eCTD submission scenarios.
- Expert Guidance – Learn directly from EXTEDO’s global regulatory expert, Michael Faust, who brings years of experience in supporting both health authorities and industry with eCTD compliance worldwide.
- Global Perspective – Stay informed on international trends shaping eCTD adoption and discover how Africa can harmonize with established practices in Europe, GCC, Asia, and beyond.
Boost Your Skills & Career – Whether you are new to eCTD or already familiar, this training equips you with the confidence and know-how to drive digital transformation in regulatory affairs.
What Will You Learn?
- Fundamentals of eCTD structure and submission requirements
- Step-by-step guidance on compiling, validating, and submitting dossiers
- Best practices to ensure compliance with regulatory authority expectations
- Common challenges in eCTD implementation – and how to overcome them
Insights into global regulatory frameworks and their relevance to Africa
Training Format
- Pre-Learning Access – Once registered, participants will receive access to an exclusive e-Learning portal to prepare ahead of the training.
- Interactive Full-Day Workshop – Practical group exercises, simulations, and guided sessions with the trainer.
Mandatory Requirement – Delegates must bring their laptops for the training to fully participate in the hands-on sessions.
As a participant in the AfriSummit’s eCTD training, you will have access to the e-Learning portal as soon as you have completed your registration process.
The portal allows you to learn in your own time to prepare for the upcoming eCTD Training at the AfriSummit and support your role for eCTD submissions.
ON THE TRAINING DAY:
- Delegates must bring their laptops for the training as a mandatory rule.
MR. MICHAEL FAUST
RCC Business Consultant – EXTEDO
Since 2017, Michael has been a Business Consultant at EXTEDO, specializing in drug regulation and registration. As part of EXTEDO’s Regulatory Competence Center, he monitors regulatory standards worldwide, focusing on Europe, Asia, GCC, and the Middle East.
He is a seasoned trainer who has delivered advanced regulatory and software training to health authorities and pharmaceutical companies globally. With over six years of experience in regulatory and technical consulting, Michael brings practical expertise and deep industry insights to every training session.
EXTEDO
EXTEDO is a leading provider of Regulatory Information Management (RIM) solutions, enabling effortless compliance across the life sciences sector. Their solutions cover:
– Master Data Management (XEVMPD, IDMP)
– Document & Quality Management
– Registration & Submission Management
– Safety Management
Today, EXTEDO enables more than 35 regulatory authorities and over 1000 maintained customers across 65 countries to deliver Effortless Compliance™. Our clients range from small CROs to large multi-national pharmaceutical organizations, and we cover industries from biotech to homeopathics, and medical devices to crop sciences.
Trusted by 35+ regulatory authorities and over 1,000 clients across 65 countries, EXTEDO helps organizations—from CROs to global pharmaceutical companies—streamline regulatory processes and focus on innovation.
Learn more: www.extedo.com
| Time | Topic |
| 09:00 – 09:15 | Welcome |
| 09:15 – 10:00 | Introduction to eCTD |
| 10:00 – 11:00 | eCTD Basics and Regional Information, QC/ VAL, BP |
| 11:00 – 11:15 | Coffee Break |
| 11:15 – 12:45 | eCTD Role Play – Part 1 – Tool overview, QC and Basic Reviewing |
| 01:00 – 02:30 | Prayer & Lunch Break |
| 02:30 – 03:30 | eCTD Role Play – Part 2 – Managing Submissions and Advanced Review |
| 03:30 – 04:15 | Advanced eCTD – XML backbone and eCTD 4.0 |
| 04:15 – 04:30 | Q&A and Closing |
| 04:30 – 05:00 | End of Training |
Who Should Attend?
This training is ideal for: Regulatory Affairs professionals, Submission Managers & Specialists, Quality & Compliance Officers, Professionals involved in dossier preparation and electronic submissions, Representatives from pharmaceutical companies, biotech firms, CROs, and regulatory authorities
Reserve Your Seat Today: The AfriSummit eCTD Training is your opportunity to stay ahead of regulatory digitalization in Africa and ensure your organization is ready for the future of pharmaceutical submissions.
Date: 4th November 2025
Venue: Hilton Grand Nile Hotel, Cairo, Egypt
Seats are limited – Secure your spot now!
