With our eCTD v4 Masterclasses running, we would like to give you a behind-the-scenes look at the expert who will explore the upcoming eCTD v4 standard with you: Anjana Pindoria-Rettenberger, Director of Product Strategy. We asked her to introduce herself and share, in her own words, what you can expect in her sessions:
“I have often been told, ‘You can’t do that; it’s impossible!’ As a kidney transplant patient and someone who lifts heavy weights, I have faced enormous challenges that stood in my way. From this experience, I developed my very own strategy consisting of five key principles that can be applied wherever the word ‘impossible’ comes into play. In my Masterclasses, I will share these principles with anyone who wants to make a difference but is not sure where to start.
A new standard such as eCTD v4 may leave many regulatory professionals unsure of how to approach this challenge. That is why, in 2024, we at EXTEDO decided to conduct an eCTD v4 Masterclass - to support life sciences as well as regulators in understanding the impact within their organizations and preparing them for this new chapter in regulatory submissions. What started off small has ended up connecting an international community of like-minded individuals willing to learn, grow, and adapt together. Almost 1,000 people participated globally across regulators and the life sciences industry, embarking with us on this journey into uncharted territory - the upcoming eCTD v4 standard.
In light of current developments, such as the EMA pilot and more authorities planning to adopt this standard, we have decided to reload our eCTD v4 Masterclass and set up two additional sessions. The positive feedback we receive shows that there is still much to uncover on our joint path. But that is not all: As EXTEDO is the trusted vendor of more than 35 health authorities worldwide, we understand the questions that arise on their side as well as the issues they face with eCTD v4. That is why we are offering a dedicated Agency eCTD v4 Masterclass that is currently running. Here, health authorities can exchange ideas and learn with others who have similar questions - and maybe even some answers.
So, if you are a regulatory professional working in the life science industry or in a regulatory authority, remember that we are here for you and support you as much as we can with our expertise. If you have any questions, please feel free to contact us anytime. I am looking forward to seeing you soon!”
If you are working at a (inter-) national health authority and are interested in learning more about eCTD v4, please register for our free dedicated Agency Masterclass eCTD v4 – every session is completed in itself, so you can join anytime: https://www.extedo.com/events!
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