Outsourcing to and collaboration with third-parties in clinical trials requires a robust structure for successful vendor selection, contract design, quality monitoring and risk minimisation.

Join senior clinical operations and regulatory professionals at this exclusive roundtable discussion addressing the best strategies and tools for assessing, implementing and improving quality when partnering with clinical service providers.

The discussion will be lead by a senior Legal & Compliance Life Sciences professional, Maija Burtmanis, sharing her knowledge and experience in employing efficient and accurate strategies to mitigate legal and compliance risks.

Topics include

• Overview of China’s CFDA self-inspection regime and outcome
• Third-party vendor management: how far do you go in policing 3rd party CROs
• Effectively avoiding significant protocol deviations and data integrity issues
• Key aspects of quality assurance
• Localization and specifics of QA
• Validation and quality risk management
• Data collection technology
• Global standards and the use of such techniques as Risk Management, Quality-by-Design
• Creating an effective personnel training system, metrics & total quality management system
• Effective internal and external quality assurance auditing

The Speaker

Maija Burtmanis (LLB/BSc, LLM)

Maija is an Australian qualified senior Legal / Compliance Life Sciences Professional. She has worked as a senior lawyer and compliance professional for Pfizer, Novartis and Jn’J and has covered jurisdictions including Russia, Japan, China, India and the breadth of Asia Pacific.

During her career, Maija has worked on many aspects of legal / compliance “risk management” including the review and creation of policies which govern the conduct of foreign clinical trial programs; assistance with sensitive interactions involving patients, patient organisations and government representatives; education, training and advice on FCPA, Anti-Bribery, Code of Conduct and CIA requirements; Integrity and Ethics training; legal assistance with both internal and external investigations; corporate law strategic (M&A) projects; as well as liaison with international and local industry groups (such as PhRMA, IFPMA, AdvaMed & APEC) and healthcare professionals to advance key issues which impact the Life Sciences industry.

Recently Maija acquired an Anti-Corruption Summer Diploma from International Academy of Anti-Corruption (IACA) in Europe, and is also a member of Australian Institute of Company Directors (AICD).

Maija is passionate about the Life Sciences industry given its focus on innovation, patient safety and the development of state-of-the-art pharmaceutical and medical device products which are designed to improve life, longevity and good health.

Registration

This interactive roundtable discussion will be held over lunch (registration starts 11:30 a.m.; 12:00-2:00 p.m.) at the Fullerton Hotel, Singapore. Admission is free and strictly limited to senior professionals from both CROs and pharmaceutical companies (max. one per organization).

Who should attend this event:

• Head of Procurement
• Global Clinical Study Manager
• Senior Director, Clinical Development Operations
• Head Clinical Operations
• Senior Regulatory Affairs Managers
• Director, Clinical Operation
• Head of Strategy and Operations
• Chief Operating Officers
• Country and Clinical Operations Director

This executive roundtable is sponsored by Lionbridge, one of the world’s largest providers of translation and languages services for the life sciences industry.