Eurofins Seminar: Understanding Biocompatibility Basics for Medical Devices, 3rd May 2018
Event Date: 3rd May 2018, Thursday
Event Venue: Courtyard by Marriott Sydney-North Ryde, 7/11 Talavera Rd, North Ryde NSW 2113
We are pleased to be organizing this FREE event for all of our clients.
Proposed Schedule
| Time | Activity |
| 1230-1300 | Registration |
| 1300-1330 | Light Sandwich Lunch |
| 1330-1530 | Seminar: Understanding Biocompatibility Basics for Medical Devices |
| 1530-1615 | Q&A |
Overview
Navigating the technical and regulatory pathways for combination products is challenging enough when considering the complex requirements dictated by both the pharmaceutical and medical device components. The challenge increases when facing the subtle nuances imposed by regulators when filing in multiple international markets. FDA’s guidance document on ISO 10993-1, issued in June 2016, provides additional considerations for biocompatibility testing that pharmaceutical companies should be mindful of as they develop their combination products.
Join this informative seminar to learn how to implement an efficient testing program for assessing the biocompatibility of a combination product’s device component, which incorporates the relevant requirements of ISO 10993-1, to satisfy both US and international regulatory agencies.
This presentation will include real-world case studies and best practices for
- Chemical characterization, including extractables and leachables testing
- Toxicological risk assessments
- Biocompatibility testing
- Pitfalls to avoid while developing testing plans
- Future trends for combination products
- Implications of new FDA guidance on the use of ISO 10993-1
Who Should Attend
Bio/pharmaceutical scientists, managers and directors who are responsible for the development, biocompatibility assessment, and US and International regulatory submissions of combination products.
About the speaker
Odete Mendes, DVM, PhD, DACVP, DABT
Director of Toxicology and Pathology
Product Safety Labs (PSL)
As Director of Toxicology and Pathology, Dr. Mendes is responsible for direct technical oversight for toxicological and pathology assessment of preclinical testing. She provides regulatory guidance related to the pharmaceutical, medical device, biotechnology, nutraceutical and agrichemical industries. She is a diplomate of the American Board of Toxicology and of the American College of Veterinary Pathologists with extensive toxicology experience.
Immediately prior to joining PSL, Dr. Mendes served as Senior Staff Pathologist (Drug Safety and Pharmacometrics) at Regeneron Pharmaceuticals. She previously was Lead Research Investigator (drug safety evaluation/toxicology) in the department of preclinical safety at Sanofi US. In these positions, she advised drug development teams on toxicology and pathology GLP study design, toxicology development plans, and data interpretation; contributed to regulatory filings; and interacted with internal experts and regulatory agencies including FDA and EMA. She also helped develop efficacy, investigational and translational animal models for drug discovery.
Dr. Mendes earned her Ph.D. in Pathology at Texas A&M University and obtained her Diploma of Veterinary Medicine at Lisbon Veterinary Medical School (Portugal).
Registration is FREE for this event. Please email us with the following details to register.
Name, Company, Position in Company, Email Address