eCDT 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.
- Delegates will be allowed on eLearning after the training.
- Delegates will get access free for 1 month to allow them to complete their certification
Here is a preview of what to expect with a free eLearning demo:
Mr. Kent Briggs
Director – VECTOR Life Sciences (Pty) Ltd
Kent Briggs is the Managing Director at VECTOR Life Sciences. He began working with eSubmissions in 2002 and eCTDs when they were first implemented in 2003. He has provided industry workshops in the US, Canada, Europe, South Africa, India and Australia and has performed application compilation training with both big and small pharmaceutical companies around the world.
In addition to performing evaluator training at over 20 health authorities, Kent has authored the eCTD specifications for 4 regions including the soon to be released specifications for ECOWAS. Since 2014, Kent has focused on the CTD in Africa and supporting the harmonization efforts through regional and continental activities.
LORENZ Life Sciences Group
Supported by VECTOR Life Sciences Ltd. (Pty)
LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market for over 30 years. The LORENZ Regulatory Information Management solutions address industry, health authorities and academia to ensure compliance enforcement worldwide. In Africa, LORENZ is supported by VECTOR Life Sciences (www.vectortech.africa) as a partner for distributing and implementing LORENZ e-Regulatory solutions.
| Time | Topic |
| 09:00 – 09:15 | Introduction and confirm Laptops are pre-loaded |
| 09:15 – 10:00 | Document Management and upload of documents |
| 10:00 – 11:00 | Compile first Sequence |
| 11:00 – 11:15 | Coffee Break |
| 11:15 – 12:45 | Document Quality Control |
| 01:00 – 02:00 | Lunch Break |
| 02:30 – 03:30 | Publishing |
| 03:30 – 04:15 | LifeCycle Management |
| 04:15 – 04:30 | Coffee Break |
| 04:30 – 05:00 | eLearning for Certification |
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