Companies attempting to comply with Medical Device Regulation (EU) 2017/745 (MDR), introduced in May 2021 for medical device certification in the EU are challenged by the complexity and scope of the requirements. It is important for medical device companies to understand the latest requirements in the EU MDR, to minimize the risk of non-compliance and inability to certify products in the EU.
Register to gain a clear understanding of the essential EU MDR requirements for medical device registration and vigilance.
Speakers
Aarekh Shrestha, Sr. Manager and Head of Drug Safety/Device Vigilance, Veranex DM&A
Dr. Aarekh Shrestha is Veranex’s Sr. Manager and Head of Drug Safety/Device Vigilance, managing pharmacovigilance (PV) support for clinical/postmarketing PV projects. Aarekh has over a decade of experience in the PV services industry, where he has worked in multidisciplinary cross-functional teams and helped set up and manage PV requirements for small, mid-size and large pharma and medical device companies for global regulatory requirements. In his prior commitments, he has worked in companies such as Bioclinica and IQVIA before joining Veranex (Quartesian then) in 2020.
Message Presenter
Garima Tripathi, Sr. Drug Safety Physician, Veranex
Dr Garima Tripathi, Sr. Drug Safety Physician at Veranex, has more than a half a decade of experience in the pharmacovigilance services industry, with extensive experience in pharmacovigilance and device vigilance for both clinical and postmarketing activities. She also provides great insight in signal detection and literature review activities. In her earlier roles, she worked with Apcer Life Sciences, Bioclinica, and IQVIA before joining Veranex (Quartesian then) in 2021.
Message PresenterWho Should Attend?
- Regulatory affairs/compliance/safety
- Outsourcing management
- Auditing/QC/QA
- Nonclinical, clinical and commercialization segments
- Global
What You Will Learn
Attendees will learn:
- The nuances and requirements of the latest European Medical Device Regulation (EU MDR)
- How drug and device vigilance requirements compare
- The reporting requirements for both clinical investigations and postmarketing
Xtalks Partner
Veranex Data Management & Analytics
Veranex Data Management & Analytics offers EDC Builds, Clinical Data Management, Statistical Programming and Biostatistics, Pharmacovigilance and Postmarket Surveillance, Medical Writing and Regulatory Publishing, and Data Aggregation and Visualization. Our reliable, global Data Management Ecosystem allows us to ensure a high-quality deliverable and superior value. CROs, big pharma, biotech companies, and medtech companies trust Veranex to be their data management and analytics partners.
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