eCTD Workshop
Enhance your knowledge of electronic Common Technical Document (eCTD) at AfriSummit’s specialized training.
Dive into the intricacies of eCTD submission formats, regulatory requirements, and best practices. Gain practical skills to navigate the electronic submission process effectively, ensuring compliance and efficiency in pharmaceutical regulatory affairs.
Stay ahead in the ever-evolving landscape of eCTD with industry experts and interactive sessions.
During the eCTD Training at AfriSummit, you’ll have the opportunity to learn from experienced professionals who will guide you through the key components of eCTD preparation, validation, and submission.
Explore case studies and real-world examples to deepen your understanding of eCTD implementation challenges and solutions. Gain valuable insights into global regulatory trends and updates impacting eCTD adoption.
Whether you are new to eCTD or seeking to enhance your existing knowledge, this training will equip you with the skills and confidence to navigate the complexities of electronic submissions and propel your regulatory success forward. Don’t miss out on this invaluable opportunity to master eCTD at AfriSummit.
Join us for comprehensive eCTD training at AfriSummit and unlock new possibilities in streamlined regulatory submissions.
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 supports the EXTEDO team as Business Consultant, focusing on drug regulation and registration. He is active in EXTEDO’s Regulatory Competence Center, where he monitors regulatory standards worldwide. His focus regions are Europe, EAEU, Asia, and the Middle East including GCC countries.
Michael is a professional regulatory and software trainer for EXTEDO’s customers globally. He manages customer projects, provides advanced regulatory customer support, and publishing services. He has more than six years of experience with regulatory and technical, tool-specific consulting on EXTEDO’s product portfolio in projects with industry and agency customers worldwide.
EXTEDO
EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM). We focus on optimizing our clients’ eRegulatory business processes and provide a platform covering the entire regulatory landscape:
– Master Data Management (XEVMPD, IDMP)
– Document Management
– Quality Management
– Registration Management
– 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.
Our mission of Effortless Compliance™ ensures that organizations can spend more time doing the things they want to do, rather than the things they have to do. For more information visit 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 |
