Optimizing CER and PMS Document Writing with Technology and AI – Webinar in partnership with Medtech Intelligence

• What: Webinar in coordination with Medtech Intelligence examining the common non-conformities encountered during clinical evaluations and explore how technology can play a pivotal role in resolving these challenges.
• When: September 26th, 2023, 10:00 am – 11:00 am EST
• Where: Online Event
• How: Register Here – this webinar will include a 45-minute presentation and 10 to 15 minutes of Q&A.

This session will delve into common non-conformities encountered during clinical evaluations and explore how technology can play a pivotal role in resolving these challenges. We will also discuss practical process adjustments made to prevent the recurrence of these non-conformities in subsequent reviews. Gain insights into the practical application of technology to address regulatory hurdles and improve submission outcomes.

1. Shruti Sharma, Product Specialist, Regulatory Services, Celegence

Shruti Sharma is an accomplished Product Specialist for CAPTIS™, leveraging a strong background in Medical Writing.

With over 7 years of expertise in Medical Device Regulatory Affairs, Shruti excels in Clinical Evaluations for Medical Devices across diverse therapeutic areas. Her proficiency extends to crafting essential regulatory documents, including CEPs and CERs, PMSRs, and SSCP, along with MDR compliant comprehensive CEP and CER templates for medical device manufacturers, tailored to the requirements of their product portfolio. She brings this unique blend of experience to the role of moderator for the webinar, seamlessly connecting Medical Writing and Technology for insightful discussions.

2. Dr. Pratibha Mishra, Manager, Medical Device Services, Celegence

Pratibha has a master’s degree in Oral Medicine and Maxillofacial Radiology and has previously worked as a clinician and lecturer. Authored and reviewed templates and regulatory documentation for medical devices covering a wide range of therapeutic areas including dentistry, cosmetic surgery, diagnostic imaging, interventional radiology, general and electrosurgery, and many more.

Provides strategic advice to Celegence clients on regulatory strategy for clinical evaluation, PMS including PMCF, and Clinical Evidence pathways. Leads a team of qualified medical writers. Successfully completed several projects related to addressing Notified Body observations on the road to CE Marking of medical devices under EU MDR.

3. Parvathi Nambiar, Team Lead, Medical Device Services, Celegence

Parvathi has a master’s degree in microbiology, and an overall 6 years of experience in Medical Writing for Pharma and Medical Device Regulatory Affairs. She has authored and reviewed post-market surveillance (PMS) documents and Clinical Investigation Plan (CIP) and Clinical Study Report (CSR).

At Celegence, she leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices belonging to a wide range of therapeutic areas including all specialties of dentistry, radiosurgery, diagnostic imaging, in vitro fertilization (IVF)/assisted reproductive technology (ART) devices, cardiac defibrillator, and female health products.

• Understand Notified Body Expectations: Participants will develop a clear understanding of the specific criteria and key aspects that notified bodies prioritize during their review of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Clinical Development Plans (CDPs)
• Enhance Efficiency in Documentation: Participants will learn practical strategies and tips to enhance efficiency when managing regulatory documentation.
• Embrace Technology as a Strategic Investment: Participants will gain insights into viewing technology as a powerful tool for long-lasting compliance and ease of maintenance. They will learn to see technology adoption not just as a short-term solution, but as a strategic investment that pays off in sustainable regulatory compliance and streamlined maintenance processes.

This webinar is perfect for and geared towards:

• Medical Device Manufacturers
• Top management / VPs
• R&D managers
• Regulatory Affairs Professionals
• Quality Assurance Professionals
• Medical Device Executives
• Technical Writers and Managers
• Medical Writers / Reviewers
• Medical Device Executives
• Clinical Managers

Celegence offers regulatory solutions and services that are tailored to the needs of medical devices and In Vitro Diagnostics (IVD) manufacturers. The benefits of our solutions and services include clear visibility and control over diverse product portfolios, increased operational efficiency, lowered costs, and ongoing regulatory compliance. 

“Optimizing CER and PMS Document Writing with Technology and AI” webinar will be held on Tuesday, September 26th at 10:00 AM ET. Make sure you secure your spot at the webinar by registering now.

We are happy to share our insights with you through the webinar with Medtech Intelligence. For more information on how Celegence can help improve your regulatory compliance, reach out to us at info@celegence.com, contact us online or read more about Celegence’s services.