Tech-Empowerment in Medical and Technical Writing
Automations, Templates, and AI
Workshop for Pharmaceutical and Medical Device manufacturers
Tuesday, April 15th | Boston, MA
Format
In person
Timing
Workshop: 2pm – 4:30pm
Cocktail hour: 4:30pm – 6pm
Location
Boston, MA, USA
Venue
7th Floor, 75 State Street, Boston, MA 02109
Join us for an in-person workshop exploring how AI is already transforming regulatory writing across pharmaceutical and medical device industries.
The workshop will focus on how AI-driven solutions streamline submissions, enhance accuracy and quality, and optimize resources.
Our speakers include Celegence’s COO, Punya Abbhi, CDO, Lakshmeenarayana G Goundalkar, and a guest speaker Jason Mattis, Head Global CMC Regulatory Affairs at Kenvue, who will share real-world experience and insights on AI strategy including plans for monitoring and using AI output. This is an opportunity to engage in thought-provoking discussions, see practical AI applications in action, and gain actionable strategies for your own organization.
What to Expect:
✔ Practical insights on AI’s role in regulatory writing
✔ Key efficiencies AI brings to submission processes
✔ Real-world experiences from industry leaders
✔ Interactive discussions with experts and peers
This workshop is designed for professionals in regulatory affairs, medical writing, and related roles looking to adopt AI-driven efficiencies.
Time | Session Details |
---|---|
2:00 PM | Arrival, refreshments, and networking |
2:30 PM | Welcome session with an overview of technology’s role in regulatory affairs |
3:00 PM | Workshop |
4:30 PM | Food, drinks, and networking |
This in-person workshop is tailored to senior regulatory professionals in the pharmaceutical and medical device sectors.
Medical Device manufacturers:
Senior leaders in regulatory and clinical affairs from the medical device industry, including VPs and Directors, looking to explore AI-based solutions for streamlined compliance and data management.
Pharmaceutical manufacturers:
Senior professionals in regulatory affairs and CMC from the pharmaceutical sector, including VPs, directors, and senior managers seeking to optimize regulatory submissions with lean authoring and publishing tools.
Logistics
Venue: 7th Floor, 75 State Street, Boston, MA 02109 | Website
Travel information:
- 75 State Street is situated in the heart of Boston’s downtown area.
- The building offers convenient access to the MBTA public transportation system.
- It is situated 10 minutes from North and South Station, and is a short walk from the State Street, Government Center, and Park Street T Stations.
Frequently Asked Questions
Q. What is the cost?
A. This workshop is free to attend.
Q. Who should attend?
A. If you are:
Medical Device manufacturers:
- Senior leaders in regulatory and clinical affairs, such as VPs and Directors, looking to explore AI-based solutions for streamlined compliance and data management.
Pharmaceutical manufacturers:
- Senior professionals in regulatory affairs and CMC, including VPs, directors, and senior managers aiming to optimize regulatory submissions using lean authoring and publishing tools.
Q. How can I register?
A. You can register by completing the form here. Spaces are limited, so early registration is recommended.
Q. Can I bring a colleague?
A. Yes, but they will need to register separately. Please ask them to complete the registration form. Their eligibility will be reviewed before we confirm their attendance.
Q. How do I find the venue?
A. You can find travel information here.
Q. I need accommodation. Where can I stay?
A. Here’s a list of hotels near the venue. Please note that Celegence does not endorse any specific hotel.
Q. What’s included?
A. Your workshop experience includes:
- Access to sessions and expert-led discussions
- Workshop materials
- Networking opportunities
- Complimentary food and drinks.
Q. Do I need to prepare anything?
A. To get the most out of the workshop, consider the challenges you face in medical or technical writing. Bringing specific questions or scenarios will help you engage with our experts more effectively.
Q. What will I gain from attending?
A. Here’s a sneak peak of what you will learn from attending:
- Practical insights on AI’s role in regulatory writing
- Key efficiencies AI brings to submission processes
- Real-world experiences from industry leaders
- Interactive discussions with experts and peers
Q. I can no longer attend. What should I do?
A. Please inform us as soon as possible so that we can offer your place to another participant. Contact us at info@celegence.com.
Got another question?
Feel free to reach out to us at info@celegence.com
Jason Mattis Head, Global CMC Regulatory Affairs, Kenvue With over 23 years of experience in CMC, Jason Mattis specializes in manufacturing, quality, and regulatory affairs, with a focus on biologics and vaccines. He currently leads global OTC drug introduction and life cycle management at Kenvue. Previously, at Johnson & Johnson’s Consumer division, he managed regulatory strategies for OTC products. He holds a BS in Biology, an MS in Quality Assurance/Regulatory Affairs, and an Executive MBA. |
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Lakshmeenarayana G. Goundalkar Chief Delivery Officer With over 18 years of experience in regulatory services and life sciences technology, Lakshmeenarayana (LGG) leads global delivery at Celegence to help companies implement high-quality regulatory solutions across pharmaceuticals, medical devices, and biologics. Previously, as Vice President of Regulatory Services, he managed global delivery teams and supported 30+ life sciences companies. He holds a degree in software product design, development, and project management. |
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Punya Abbhi COO and Co-Founder Punya Abbhi is the Chief Operating Officer and Co-Founder of Celegence. At Celegence, Punya is focused on realizing our vision for increasing efficiency through technology. Punya’s key responsibility is overseeing the development of our MDR/IVDR compliance platform, CAPTIS®, as well as our Dossplorer™/Dosscriber™ solutions which unlock efficiencies in management of data & documents for the pharmaceutical industry. |
Register for the Workshop
Sign up today to gain exclusive access to hands-on strategies, practical tools, and expert guidance for leveraging AI, automation, and lean authoring in regulatory writing.
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Please note: Spaces are limited, and attendance will be prioritized for those who align with the “Who Should Attend” criteria. We will review your registration and confirm your spot shortly.