Home2019-02-25T22:59:16+02:00

1st Middle East eCTD Submission Forum
Under the patron of
Ministry of Health – DGPA&DC, Sultanate of Oman

SHERATON OMAN HOTEL Click for Reservation
Sunday 3rd March – Monday 4th March 2019

Sultanate of Oman

Ministry of Health

Directorate General of Pharmaceutical Affairs & Drug Control

Attended by Oman-MoH, SFDA, UAE-MoH, NHRA, KFDC & JFDA

Expected the largest gathering of industry and authority under one roof. Meet health authorities to state your difficulties and your wish list. Meet software vendors face to face and explore their software features and costings. Be part of advances, whether in eCTD submission software, PV software, RIMS software or other e-pharma software.

All people involved with e-pharma are gathering for this premier conference focusing this year on e-submission while allowing opportunities to demonstrate other e-pharma solutions such as authority submission portal. Authority will present their experience on e-submission and topics like validator software incompatibilities will be discussed and recommendations taken to GCC council, flexible participation options for pharmaceutical companies are offered to encourage their attendance and contribution.

The event supported by Oman MOH Directorate General of Pharmaceutical Affairs & Drug Control (DGPA & DC).

Agenda
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Speakers

Dr. MOHAMMED AL-RUBAIE
Dr. MOHAMMED AL-RUBAIE
Director General, Directorate General of Pharmaceutical Affairs &
Drug Control.

MOH, Oman

Dr. Christa WIRTHUMER-HOCHE
Dr. Christa WIRTHUMER-HOCHE
Head of the Austrian Medicines and Medical Devices Agency, AGES Austria Agency for Health &Food Safety.

AGES, Austria

Dr. Mohammed Saleem
Dr. Mohammed Saleem
Director executive board, SIPS, senior regulatory specialist. Regulatory strategy expert and authorities liaison.

SIPS, Jordan

Karl-Heinz Loebel
Karl-Heinz Loebel
Director, Principal Consultant Regulatory Operations/Industry and Agency Liaisons, PharmaLex GmbH.

Pharmalex, Germany

Nabeela Ahmed Memon Moosa
Nabeela Ahmed Memon Moosa
Drug Registration Pharmacist

NHRA, Bahrain

Sarah Al-Maqseed
Sarah Al-Maqseed
Rregistration and Release Monitor

KFDA, Kuwait

Hassaan S. AlWohaibi
Hassaan S. AlWohaibi
Executive Director

SFDA, Saudi Arabia

Tariq Essam Nasser
Tariq Essam Nasser
Registration

MOH, Oman

Eman Ali AL-Awamleh
Eman Ali AL-Awamleh
Specialist pharmacist in charge of generic drugs assessment & sites manufacturing accreditation

JFDA, Jordan

Michael Gessert
Michael Gessert
Global Agencies Manager and Managing

Extedo, Germany

Sara K. Almuteb
Sara K. Almuteb
Drug Registration Pharmacist

Gulf Health Council, Saudi Arabia

Sponsors

Diamond

Gold

Silver

Support

eCTD in the Middle East

Online Training of eCTD Content and eCTD Submission

Find out more