A primary goal in medical device clinical studies is maximizing a patient’s safety while determining the products efficacy and effectiveness. In order to ensure the greatest degree of safety, adverse event reporting is required in both pre- and post- market phases of development. The former GHTF released guidance regarding pre-clinical trials adverse event reporting (SG5:N5:2012) citing the unique pre-clinical safety problems, but also the newly proposed MDD includes requirements for pre- and post-market adverse event reporting. These newly recommended standards come as additional challenges for clinicians who are also preparing for the clinical provisions outlined in the medical device drafted regulation.
- Updates on current standards and proposed MDD revision
- Defining adverse event (AE) and serious adverse events (SAE)
- Guidance and timelines for pre- and post-market AE and SAE reporting
- Clarification on common misinterpretations of guidelines
- Challenges and strategies for implementing pre- and post- market regulations
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Clinical Operations/Development
- Clinical Research
- Clinical and Regulatory
- Clinical Safety and Reporting
Annet Muetstege, PhD
Applied Clinical Services
Annet Muetstege, PhD, Director, Applied Clinical Services
Annet Muetstege has a MSc degree in Medical Biology, a PhD in Medicine, and more than 20 years of Clinical Research, Outcome, and Quality experience. In Academia, Annet developed and ran research projects in diabetes, gynecology and nephrology, and wrote several publications. After obtaining her PhD, she pursued her career in Health Care Industry and led clinical evidence based efforts connecting different expertise’s such as marketing, regulatory and reimbursement to clinical operations. Annet has built and led teams of clinical research professionals and overseen the design and execution of more than thirty pre and postmarket European and global trials in cardiology, gynecology, urology, nephrology and oncology. Annet is director and co-founder of Applied Clinical Services BV.