The SQA Regulatory Forum hosted an international symposium entitled, “Global Regulatory Compliance Challenges,” 26 – 27 October 2009 at the Hyatt Regency Penn’s Landing in Philadelphia, Pennsylvania, USA. The symposium’s speakers came from around the globe, including Africa, Brazil, China, France, Germany, India, Japan, Korea and the US, featuring government regulators from Africa, China and the US.

Globalization heightens the need for an understanding of the regulatory framework and of achieving compliance in all corners of the world. However, the efforts required to achieve compliance are not necessarily obvious and require special consideration. This symposium explored global compliance issues encountered by regulators and the regulated community, with a focus on interactions with countries that are not members of the OECD, e.g., China, India and Brazil. In addition, a speaker described compliance issues in Africa. Using real-life situations to illustrate the lessons learned and paths toward global regulatory compliance, the symposium included formal presentations and interactive sessions about cultural and language challenges and compliance issues.

The following industries working with facilities in OECD non-member countries benefited from participation:

Quality Assurance professional
Study sponsor or monitor
Study Director or scientist
Facility management or regulatory affairs professional
Regulator

AGENDA:

Monday, 26 October 2009

7:30 am – 8:30 am	*Continental Breakfast and Registration*
8:30 am – 9:00 am	Symposium Introduction and Housekeeping
9:00 am – 10:00 am	Plenary Speaker: "The Impact of Cultural Issues on Establishing GLP Programs in Developing Countries," Robert R Stewart PhD, Technology Sciences Group Inc, USA
10:00 am – 10:30 am	"The Current Status and Challenges of Implementing a GLP Program in China," Xiuwen Wang, State Food and Drug Administration, China
10:30 am – 10:45 am	*Networking Break*
10:45 am – 11:15 am	"Establishing a GLP-Certified Laboratory in China: A 15-Year Journey towards GLP Compliance," Xigeng Bai PhD, Shenyang Research Institute of Chemical Industry, China
11:15 am – 11:45 am	"Challenges in Working under Both US FDA and China SFDA GLPs," Jinsong Xing PhD, WuXi AppTec Co Ltd, China
11:45 am – 12:15 pm	"GLP Laboratories in China and Their Compliance Status," Joe Zhang, Roche R&D Center Ltd, China
12:15 pm – 1:15 pm	*Lunch*
1:15 pm – 2:00 pm	"Multi-Site Study Conduct: The Challenge of GLP Compliance to Conflicting Global Interpretations," Kathrin Ertz and Martina Preu PhD, Bayer, Germany
2:00 pm – 2:30 pm	"GLP Quality System and Compliance Monitoring in India," Labhu U Sanghani PhD, Jai Research Foundation, India
2:30 pm – 3:00 pm	"The Conduct of Multi-Site Studies within and across Geographies: Constraints, Complexities and Compliance," written by Natesan Settiagounder PhD, Advinus Therapeutics Private Ltd, India, presented by William D Barta, WDBarta QA Consulting, USA
3:00 pm – 3:15 pm	*Networking Break*
3:15 pm – 3:45 pm	"Navigating Global Registration of Genetically Modified Crops in Changing Regulatory Environments," Beryl J Packer PhD, Monsanto Company, USA
3:45 pm – 4:30 pm	"US EPA Technical Cooperation with Asia and Latin America on Good Laboratory Practices," Francisca E Liem, US Environmental Protection Agency, USA
4:30 pm – 5:30 pm	Q&A Session with Monday’s presenters
6:30 pm – 9:00 pm	Informal Dine-arounds with Colleagues

Tuesday, 27 October 2009

7:30 am – 8:30 am	*Continental Breakfast and Registration*
8:30 am – 9:00 am	"Comparison of the Practical GLP Interpretation among US, UK and Japan," Yoshikazu Hasegawa, Japanese Society of Quality Assurance, Japan
9:00 am – 9:30 am	"Current Status and Perspectives on Korean GLP," written by Il Je Yu, Korea Environment & Merchandise Testing Institute, Republic of Korea, presented by Elliott Graham RQAP-GLP, Society of Quality Assurance, USA
9:30 am – 10:00 am	"African Biosafety Network of Expertise: Building Biosafety Regulatory Programs of African Countries," Allan Liavoga PhD, African Biosafety Network of Expertise, Burkina Faso
10:00 am – 10:15 am	*Networking Break*
10:15 am – 10:45 am	"An Experience in Developing a GLP Operation for Field-based Research in Brazil," Fábio S Tagliaferro, Monsanto do Brasil Ltda, Brazil
10:45 am – 11:15 am	"Brazilian System of Agriculture Inputs Inspection: The Official System to Measure the Brazilian Companies’ Compliance," Luís Eduardo Pacifici Rangel, Ministry of Agriculture, Brazil
11:15 am – 11:45 am	"Differences in the Interpretation of the GLP Requirements by OECD Monitoring Authorities: The point of view from the pharmaceutical industry," Raymond K Lowing PhD, Sanofi-Aventis R&D, France
11:45 am – 12:00 pm	"An Update on Health Canada’s Initiative to Establish a GLP Monitoring Authority (GLP-MA)," Paul Sidney RQAP-GLP, Charles River Laboratories Preclinical Services, Canada
12:00 pm – 12:30 pm	Q&A Session with Tuesday’s morning presenters
12:30 pm – 1:30 pm	*Lunch*
HOT TOPIC: Computer System Issues Worldwide
1:30 pm – 2:00 pm	"Challenges in Global Software Development and Implementation from a Contract Research Organization Perspective," Randy Basinger, Quintiles Inc, USA
2:00 pm – 2:30 pm	"Implementing Global GCP Computerized Systems: Preparing and Managing the Global Project," Patricia M Miller, SAS Institute Inc, USA
2:30 pm – 3:00 pm	"GxP Regulatory Compliance Challenges for Global Data and Document Management," Kim Nitahara, META Solutions Inc, USA
3:00 pm – 3:15 pm	*Networking Break*
HOT TOPIC: Shipping Materials Globally for GLP Research
3:15 pm – 3:45 pm	"Helping to Ensure the Integrity of Your Samples during Global Transport," Michael Gordon, World Courier, USA
3:45 pm – 4:15 pm	"International Shipment of Test Articles and Biological Matrices," Christopher McEvoy, Charles River Laboratories Preclinical Services, Canada
4:15 pm – 4:45 pm	Q&A Session with Tuesday’s Hot Topics presenters
4:45 pm – 5:30 pm	Symposium Closing and Discussions for the Future
5:30 pm – 9:00 pm	*Networking Reception*, sponsored by the Mid-Atlantic Region Society of Quality Assurance (MARSQA)