International Trials and ICH

Download Breakout Session Overviews  | Download Schedule of Breakout Sessions | View Conference Schedule

2022 Agenda

Thursday, September 15, 2022 at 1:15 pm to 2:00 pm ET                          Track: International Trials and ICH

Comparing Clinical Research Regulations for Medical Devices

There have been multiple regulatory changes recently for medical devices and clinical research. All these regulatory changes have influenced the need for clinical evidence requirements for medical devices and the need for the conduct of wider clinical investigations and extensive clinical evaluations has become a mandate. However, in the current situation, the clarity and comparative intelligence of the medical device clinical research-oriented regulations is grossly missing. In this presentation, the speaker intends to cover the regulations of various countries (US, EU, UK, Canada, EEA, MERCORSUR, ASEAN, India, Australia etc.) 213
Presenter: Ashish Indani, BHMS, MBA, MIRCS, Sr. Manager Clinical Affairs, Stryker

Thursday, September 15, 2022 at 2:05 pm to 2:50 pm  ET                         Track: International Trials and ICH
GCP Inspections by Argentina Health Authority National Administration of Medicines, Food and Medical Technology (ANMAT)

Clinical site inspections by regulatory agencies vary by region. Mr. Purnell will highlight regional regulatory challenges and differences in regulatory inspection in Argentina. How sponsors can best support local sites in this region and how sites can adequately prepare for inspections will be discussed, as will inspections in Argentina versus FDA inspections of clinical sites. 215
Presenter: Terrence Purnell, MS, CCRP, RQAP-GCP, Head of CQA Operations, Americas, CSL Behring

Friday, September 16, 2022 at 11:00 am to 11:30 am ET                     Track: International Trials and ICH
EU & UK privacy laws – Implications for Clinical Trial sponsors processing EU/UK personal data

Rob Masson, CEO of The DPO Centre will be discussing the most important issues US clinical trial sponsors need to consider when acting as the Data Controller for personal data collected from EU & UK trial participants. The presentation will cover the impact of the Clinical Trial Regulation, the introduction of the CTIS, the requirements around EU & UK Representation and the considerations for cross boarder data transfers. 219
Presenter: Rob Masson, Chief Executive Officer, The DPO Centre