11th Middle East Regulatory Conference (MERC) 2015

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11th Middle East Regulatory Conference (MERC) 2015
Regulatory Science and Best Practices Bringing Innovative Medicines to Patients

This is the 11th DIA Middle East Regulatory Conference (MERC) in partnership with the Middle East Regulatory Network (MERN). The DIA supports positive collaboration in the region by remaining a neutral information forum; dedicated to advancing the field by drawing on its rich global community of industry, regulatory and academic professionals.

The MERN is a regional network of the EFPIA (European Federation of Pharmaceutical Industries and Associations). The MERN works in partnership with regulatory authorities and the pharmaceutical industry in the Middle East to develop legislation and regulatory practices that enable patients to have access to good quality medicines, including innovative medicines in line with international standards.

This Conference marks an important milestone – it will celebrate the 20 year anniversary of MERC and an opportunity to reflect on the significant progress made over that period. And for the first time in that 20 year period, MERC is being co-hosted by a regulatory authority - Saudi Food and Drug Authority (SFDA).

As an important forum related to the provision of healthcare in the region, it will continue to discuss the opportunities to achieve further improvements for faster access to new, and improved medicines and therapies for the population in the Middle East region. It provides a forum for all participants to contribute to active discussion and identify actions to expedite access of valued innovative medicines to Middle Eastern patients.

Co-hosted by SFDA "Saudi Food & Drug Authority"

This year’s conference will explore advances in regulatory science and discuss the benefits of regulator collaboration & convergence. It will ask how this can be put into practice to meet the challenges of assessing innovative medicines.

KEY TOPICS:

• SHARING PROGRESS AND LEARNINGS FROM LOCAL REGULATORY ENVIRONMENT

Focus on sharing best practice, experience and learnings from a number of recent, positive changes that have been implemented by Middle East Regulators.

• PROGRESSIVE REGULATORY PATHWAYS – THE WAY AHEAD

Share new developments in regulatory science - how innovative regulatory pathways can strenghten regulatory review.

• ENSURING QUALITY THROUGH COMPLIANCE

Deliver the right drug at the right place at the right time - key quality aspects of manufacturing, analytical testing, release and distribution. Promoting global harmonisation of standards for regulators, industry and patients. 

• eCTD AND PRACTICAL EXPERIENCE SHARING

Experiences, best practices, challenges and opportunities.objective is to review some of the paradigm shifts in technical research and development.

• REGULATORY PRACTICES ADDRESSING SCIENTIFIC AND THERAPEUTIC INNOVATION 

Review paradigm shifts in research and development - how changes in disease understanding are influencing regulatory pathways.

• DILIGENT ASSESSMENT OF BIOSIMILARS ENSURING PATIENT SAFETY

Ensure timely accessibility of high quality efficacy & safety profile bio-therapeutics to patients of the Middle East patients.

• PHARMACOVIGILANCE

Share information on pharmacovigilance infrastructure, reporting and pre- & post-approval.

The conference offers the opportunity for key stakeholders active or interested in this diverse and changing region, including representatives from regulatory agencies, ministries of health, local and multi-national pharmaceutical companies, to meet to exchange views, discuss topics of interest and identify actions to increase patient access to new and improved medicines and therapies.

• Understand recent changes in the local regulatory environment including examples of new initiatives and future developments
• Discuss the challenges faced by regulators for increasingly innovative and complex therapies
• Identify new regulatory pathways to secure early and sustainable access to innovative therapies across the region
• Create an opportunity for all stakeholders in the region to collaborate on key regulatory issues related to the availability of innovative medicines and therapies