The Programme

Registration

Opening remarks from the Chair

Optimising country selection: factors to take into account

• Deciding on the possible locations to run a clinical trial
• Considering factors such as size and relevance of the patient population
• Choosing the most appropriate region to ensure maximum results

Graciela Rácaro
Senior Director
Latin America Operations
PAREXEL International

Evaluating the feasibility of conducting clinical trials in emerging regions: strategies and lessons learned

• Feasibility studies for adequate country/site selection and patient recruitment projection to meet last patient in
• Study start-up strategy: key topics to avoid delays
• Challenges and benefits of emerging markets versus developed countries
• Today's competitive landscape and future markets

Are emerging markets the answer?

• Exploring the advantages of clinical trials in emerging markets
• Recognising the obstacles to be tackled
• Developing optimal clinical trial approaches in emerging regions

Morning refreshments

Dr Sarah Arbe-Barnes
General Manager, Product Development Consultancy
Fulcrum Pharma

Detailing obstacles when running clinical trials in developing countries

• Optimising deliverables from public funding for neglected diseases
• Reviewing the trial sites: Africa and South East Asia
• Highlighting the challenges of setting up and running clinical trials
• Establishing solutions

Exploring the opportunities and obstacles to the expansion of clinical research markets in Poland and Russia

• PMR’s findings on the possibilities of relocating clinical trials to Poland and Russia
• Average registration time in Pl, Russia
• Recent important trends and events in these markets
• Comparison to other Central and Eastern European countries

Dany Dagher
Business Development Manager
MEK Consulting

Exploring the MENA region: a SWOT analysis and past experience

• Understanding the regulatory environment
• Presenting a SWOT analysis
• Reviewing our track record to-date

Managing international R&D expansion successfully by choosing the right model

• Evaluating the size of opportunity available
• Picking the right location
• Centralised vs decentralised trial management models
• Choosing service providers
• Validating the concept

Lunch

Case study on Eastern Europe: clinical trials in Bulgaria

• Reviewing the challenges of setting up trials in Bulgaria
• Ensuring the trial design takes local infrastructure and site constraints into account
• Highlighting the regulatory issues to be aware of
• Maximising drug development in Eastern Europe

Hoda Tawfik
Director, Global Clinical Operations
MEDIGENE

Clinical trials in India: a sponsor’s perspective

• Reviewing the benefits of setting up clinical trials in India
• Assessing how to overcome the challenges
• Highlighting the best strategy for advancing clinical trials

The challenges of conducting clinical trials in emerging markets

• An overview of Glaxosmithkline's presence in the MENA area
• Availability of epidemiological data
• Capacity building
• Cultural awareness
• Access to medicines

Overcoming the challenges of clinical trials in Africa

• Reviewing the obstacles faced
• Highlighting best practice techniques
• Focusing on trials in South Africa
• Ensuring the number of clinical trials continue to grow in Africa

Closing remarks from the Chair

End of day one and drinks reception sponsored by Almac

Registration

Opening remarks from the Chair

Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of clinical trials in emerging markets

12:30

Lunch

Relocating later phase trials to emerging markets

Conducting Phase IIIb/IV studies in emerging markets

• Why perform phase IIIb/IV studies in emerging markets?
• Exploring CRO selection and training methods for local personnel
• Reviewing specific challenges for running late phase studies in emerging markets

Identifying the legislative situation in India

Reviewing the evolving regulatory requirements in India

• Outlining the different regulations which need to be met
• Addressing the challenges these will raise
• Ensuring import licenses are obtained in a timely manner
• Explaining best practice techniques for achieving compliance

Optimising CRO partnership choice

• Understanding key factors to take into account when selecting a CRO
• Choosing between smaller local and larger global CROs
• Identifying the right CRO for your needs

Afternoon refreshments

Implementing successful patient recruitment and retention

• Understanding the culture and how to reach the patient population
• Identifying the best methods of communication for effective patient recruitment
• Exploring best practice enrolment procedures

Considering the ethics of trials in developing countries

• Understanding the challenges of conducting ethical clinical trials
• Ensuring adherence to informed consent principles
• Ethics committees: their involvement and continuing checks
• CROs and ethical issues in developing countries
• Ensuring good ethical practice and a high standard of care throughout the trial
• Beyond international guidelines: addressing ethical dilemmas

Closing remarks from the Chair and Champagne prize draw

End of conference