The Workshop

PRE-CONFERENCE WORKSHOP
Conducting clinical trials in emerging regions
Date:		Monday 23 February 2009
Led by:		Graciela Racaro Senior Director, Latin American Operations PAREXEL International	Piotr Kolataj Director Clinical Operations Eastern Europe PAREXEL International	Albert Liou Corporate Vice President and General Manager Asia-Pacific PAREXEL International	Prashant Desai Director, Business Development PAREXEL INTERNATIONAL
About the workshop
Performing clinical trials in emerging regions such as Latin America, Asia, and Eastern/Central Europe calls for thorough planning. Understanding the regulatory requirements and diverse cultures in each of the different regions is key to the success of your clinical trial. This one-day workshop will focus on the critical challenges which you will face when relocating your trials into these non-traditional regions. The following challenges will be covered for each region detailed below: Regulatory environment Site selection strategy Logistic strategy Cultural differences Quality strategy Study start-up
Workshop agenda
	08:30	Registration
	09:00	Welcome Latin America
	10:30	Morning refreshments
	11:00	Central and Eastern Europe
	12:00	Lunch
	13:00	Asia-Pacific
	14:30	Afternoon refreshments
	15:00	India
	15:30	Question and answer session
	16:00	Close of workshop
About your workshop leaders
Graciela Rácaro is Senior Director, Latin America Operations at PAREXEL International. She is responsible for the implementation of clinical research studies in 14 Latin American countries, which includes overseeing submissions to regulatory authorities. Ms. Rácaro has expertise in drug development and both non-clinical and clinical research across a broad range of therapeutic areas. Her clinical experience includes clinical trial monitoring, project management and quality management in compliance with local, FDA/EMEA regulations and GCP guidelines. Prior to joining PAREXEL, Ms. Rácaro held a clinical management position at Serono International, and previously worked at the clinical research organisation EDYABE and pharmaceutical company Laboratorio Gador, S.A.

Piotr Kolataj is the Director of Clinical Operations Eastern Europe at PAREXEL International. He graduated from Medical School in Warsaw, Poland in 1985 and worked as a physician in the internal medicine department in a Warsaw hospital. During this time Piotr started organising and monitoring international clinical trials in Poland on behalf of a European CRO. He is now responsible for managing and developing the Poland office of PAREXEL International, managing and developing company structures in Russia, Ukraine, Poland, and Georgia.

Albert Liou serves as Corporate Vice President and General Manager for Clinical Research Services in Asia-Pacific and is responsible for the overall business and operations for the region. He has over 22 years of clinical research experience, of which 11 years were spent in the United States and 11 years in Asia. After working at Harvard Medical School as a Senior Statistician, he had a managerial role in biopharmaceutical Liposome Technology which later became part of Johnson & Johnson. He then worked at Amgen where he was a member of the senior management team, responsible for clinical data management. He then returned to Asia and founded APEX International which became a leading CRO in the Asia/Pacific region.

POST-CONFERENCE WORKSHOP
Optimising CRO selection when moving into emerging markets
Date:		Thursday 26 February 2009
Led by:		Roger Joby Managing Director 1to1to1
About the workshop
The key to working successfully with sub-contractors, including CROs, is to have a clear idea of what constitutes a successful project and conveying this to your suppliers. Once you have a clear idea what is important to your key stakeholders then selection of a CRO becomes easier. The process of selection also becomes easier once you know what to look for. The final parts of the puzzle concern the contract and how to measure the supplier’s performance against that contract. Earned Value Analysis and Deliverable Budgets provide that data and will give you the confidence to be more imaginative about the contractual relationship with your suppliers.
Workshop agenda
	08:30	Registration
	09:00	Planning Key performance indicators – are quality, time and cost always equally important? The business case – including the rational on where studies should be carried out Deliverables and metrics
	09:45	The Process Selection process Requests for information (RFIs) Requests for proposals (RFPs) Analysis of proposals
	10:30	Morning refreshments
	11:00	Contracts Fixed Fixed unit priced Variable – fee for service Other
	11:45	Measuring performance Earned value analysis
	12:30	Close of workshop
About your workshop leader
Roger Joby B.Sc. MAPM is the Managing Director of 1to1to1. Roger has been involved in the pharmaceutical industry for over 30 years working for both CROs and pharmaceutical companies and now as an independent consultant. Roger’s experience includes project management, proposal generation, sub-contractor contacts and project finance.
About 1to1to1
1to1to1 is part of R. & N.R. Consulting specialising in project management consultancy in clinical research. The company was formed in March 2000 and has a range of clients that include large and medium sized pharmaceutical companies, bio-techs and CROs.