Overview

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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"

Featured topics

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.

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Continuing-Education

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Learning objectives

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

Program Committee

Trevor M. Jones, CBE former Director General ABPI
King's College London, United Kingdom
Hassaan S Alwohaibi Executive Director of Regulatory Affairs Directorate
Saudi Food and Drug Authority (SFDA), Saudi Arabia
Kerstin Ahrendt-Soelter Senior Director Corporate
Biotest AG, Germany
Ihab Attia Regulatory Director
Eli Lilly and Company, United Arab Emirates
Susanne Ausborn, PhD Global Head International Regulatory Policy
Roche, Switzerland
Wadiah Issa Batarseh, RPh Regulatory affairs manger
Bayer Middle East FZE, Jordan
Hassan Bibi Director – Near East Region / Governmental Affairs, Market access and Pricing
Merck, Lebanon
Adele Choueiry Head, Regulatory Affairs, Levant Region; Lebanon Regulatory Working Group Chair
Novartis , Lebanon
Inas Chehimi Head RA Middle East & North Africa
Novartis Pharma Services AG, United Arab Emirates
Paul Dearden Senior Director, Global Regulatory Policy
Biogen, United Kingdom
Greg Jordinson, MSc Associate Director, EMEA Policy Lead, Global Regulatory Policy and Intelligence
Janssen R&D, United Kingdom
Mounay Hussein Khafaja, PharmD, MSc Regulatory Affairs Director & Regulatory Center of Excellence, IRWG Group Chair
Merck, Lebanon
Nadine Otin President
PHARMAREG International Consulting, France
Patricia Salami Senior Director, Regional Regulatory Affairs Head, MEAR Region
Merck KGaA, United Arab Emirates
Samia Gamal Seleem, PharmD, RAC Scientific & Regulatory Affairs Director
Abbvie, Egypt
Hajed M.H Hashan Deputy of General Director
Gulf Health Council, Saudi Arabia
Mohammed Hamad M. Alhaidri Executive Board Member
Gulf Health Council , Saudi Arabia
Samah Ragab Ibrahim Director of Pharmaceutical Registration
Ministry of Health, Egypt