Event Calendar

International Trials and ICH

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2019 Agenda


Friday, September 27, 1:15-2:00                                      

European Union Medical Device Regulation (EU MDR) and Its Impact on Clinical Investigations 

This session will look at how implementation of the European Union Medical Device Regulation (EU MDR) will impact clinical investigations performed by manufacturers. Topics to be discussed will include: 1) What is a clinical evaluation/CER under EU MDR? 2) When are you required to update a product’s CER? 3) What constitutes the requirement for performing a clinical investigation to support a CER submission to your notified body? 4) What impact does this have on the ability to support the safety and efficacy claims for your products? 809
Presenter: Dona Occhipinti, MPH, CCRP, 
EU MDR Clinical Evaluation Lead, Welch Allyn (A Hill-Rom Company)

This session will look at how implementation of the European Union Medical Device Regulation (EU MDR) will impact clinical investigations performed by manufacturers. Topics to be discussed will include: 1) What is a clinical evaluation/CER under EU MDR? 2) When are you required to update a product’s CER? 3) What constitutes the requirement for performing a clinical investigation to support a CER submission to your notified body? 4) What impact does this have on the ability to support the safety and efficacy claims for your products? 809

Presenter: Dona Occhipinti, MPH, CCRP, EU MDR Clinical Evaluation Lead, Welch Allyn (A Hill-Rom Company)

Track: International Trials and ICH


Friday, September 27, 2:05-2:50                                      

Being Prepared - The EU General Data Protection Regulation (GDPR)

The EU GDPR has been constituted to harmonize European data protection regulations. It has an impact on any company worldwide with revenue-generating processes based on using personal data of EU citizens. The GDPR protects data of every EU citizen, no matter where in the world the data is processed and stored. GDPR protects a broad variety of types of data, including health and research related data! GDPR was officially released in April 2016. After a two-year transition phase, the date of enforcement was May 25 in 2018. Unlike most EU regulations, GDPR is in effect without undergoing ratification of the EU member states first. The presentation covers in short, what you should know about the new regulation and how and where it affects your daily business. 811

Presenter: Gerhard Fortwengel, PhD, MPH, MSc, Professor, University of Applied Sciences and Arts, Hannover

Track: International Trials and ICH


Friday, September 27, 3:25-4:10                                     

International Variations in the Uptake and Governance of Genetic Research, Research on Gametes and Stem Cells and Cloning

The past two decades have witnessed huge leaps in medical research. While genetic research is now paving the way for personalized medicine, stem cell research continues to promise life and a cure for patients with a wide spectrum of disorders such as cancer and multiple sclerosis. Cloning has opened a whole new gate for restorative medicine and, as the case has always been in history, science and research confront traditions, beliefs and societal norms. Dr. Elmorsy will focus on the international differences in dealing with new areas of medical research, utilizing examples from countries with varying cultural and religious backgrounds. Regulations governing stem cell research, cloning, and genetic research will be compared among the USA, Europe, Saudi Arabia, a country from the Far East and another from Latin America. Such information is very important when planning multinational research in the current era when new clinical research frontiers are badly needed. 813

Presenter: Soha Elmorsy, MD, PhD
Research Consultant, King Abdullah Medical City, Makkah, the KSA
Professor of Pharmacology, Faculty of Medicine, Cairo University

 

 

Track: International Trials and ICH


Friday, September 27, 4:15-5:00                                      

Quality Control Principles and Practices to Oversee Research Projects in South America 

This presentation will address the importance of a commitment to Total Quality principles and practices as the key to successful research projects in Latin America. It provides an overview of training and general elements for running a quality control program and offers recommendations for addressing the unique challenges encountered in multisite projects. Creating a culture of quality through commitment, training, and continual improvement can enhance team performance from site selection to study closeout. Tips, tools, and best practices will be shared, along with suggestions on how to apply them in different scenarios. Ms. Wright will discuss strategies, common barriers and opportunities, and the role of the United States in partnerships for leading and monitoring investigation projects. This presentation will be based on tuberculosis trials conducted in Peru and Brazil since 2008, drawing from insights gained through training and leading clinical research personnel in multisite projects in both countries. 815

Presenter: Alicia Wright, MS, CCRP, Program Manager, Vanderbilt University Medical Center 

Track: International Trials and ICH