RAPS Regulatory Convergence 2023 – October 5th

Celegence invites you to join us for the RAPS Regulatory Convergence on 3-5 October 2023 in Montreal, QC. Join global regulatory peers, industry experts, regulatory bodies, and solution providers.

• What: RAPS Regulatory Convergence 2023
• When: Thursday, October 5th at 11:15 AM – 11:40 AM EDT
• Booth Number: 407
• Where: PALAIS DES CONGRÈS DE MONTRÉAL, Quebec
• How: Register Here
• Why: Join this session to examine the common non-conformities encountered during clinical evaluations and explore how technology can play a pivotal role in resolving these challenges.You can find the full schedule of RAPS Convergence 2023 here.

RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. Convergence brings together representatives of industry, regulatory bodies, research, academia, and clinical organizations directly involved in managing the regulatory process and aligning science, regulation, and business strategy. Convergence provides regulatory affairs professionals with the latest developments in medical devices, biopharmaceuticals, and IVDs each year.

Celegence is excited to be an Innovator Level Sponsor at RAPS Regulatory Convergence this year in Montreal, QC. Come together with other regulatory affairs professionals to discuss pressing regulatory topics and share best practices within the healthcare products sector. Our sponsored session will be led by Celegence’s Product Specialist, Shruti Sharma.

• Shruti Sharma is an accomplished Product Specialist, with a unique blend of Services and Technology experience and 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 Clinical Evaluation Plans (CEPs) and Reports (CERs), Post-Market Surveillance Reports (PMSRs), and Summary of Safety and Clinical Performance (SSCP), along with MDR compliant comprehensive CEP and CER templates for medical device manufacturers, tailored to the requirements of their product portfolio.

• 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.

• 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.

Visit us at Booth 407 for complimentary consultations with Celegence’s experts throughout the event. You can view the firsthand demo of our regulatory technology solutions that are tailored to the needs of pharmaceutical organizations, medical device and In Vitro Diagnostics manufacturers. The benefits of our technology solutions include clear visibility and control over diverse product portfolios, increased operational efficiency, lowered costs, and ongoing regulatory compliance.

To learn more, reach out to info@celegence.com, contact us online or simply stop by the booth in the exhibitor area to meet with us. We hope to see you there!

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.