Conference Schedule

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14 -18 October 2018

Cairo Marriott Hotel, Cairo, Egypt

eCTD Training
Conference Day 1
Conference Day 2
PV Training Day 1
PV Training Day 2

Session 1

Introduction to docuBridge Using Searches for Compilation Compilation Basics 1 to 1 Compilation 1 to Many Compilation Copying eCTD Sections
11:00 - 11:-30

Coffee Break

Session 2

Compiling Study Reports – Non-Clinical and Clinical Compiling Regional Content – Administrative Information and Module 1 Hyperlinks
13:00 - 14:00

Lunch Break

Session 3

Quality Checking the Application Initial Publishing, eValidation and Fixing Validation Issues Lifecycle Management – Introduction

Session 4

Lifecycle Management – New, Replace, and Delete Operations Lifecycle Management – Dealing with Hyperlinks Delta Publishing Q&A; and Wrap-Up

Session 1: Egypt Pharma regulations updates. Future agenda and current challenges

For this session we will invite Representatives of MOH & CAPA to give an overview on the latest changes and upcoming plans

Q&A; & Discussion “Future development of the Egypt Pharmaceutical Market”

For this session we will invite Egypt Pharma regulatory bodies, Ex government representatives, industry experts and our speakers from GCC & ME countries. Questions for discussion: What are the Government’s...
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10:50 - 11:20

Coffee and Networking Break

Session 2: Middle East Pharma regulation & Market access

This session will feature representatives of the ME region’s regulatory bodies & Pharma experts from Regulatory approaches to ensuring patients’ early access to drugs in Jordan & Saudi Arabia Innovations...
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13:00 - 14:00

Lunch

Session 3: Current Pharma Regulatory & Market Access landscape in Africa

For this session we will invite Official representatives from:

Round tables discussion & Afternoon tea

We will close day One of the Conference with an interactive session discussion. The audience will be divided into 9 groups. Each group will have a leader – an expert...
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Breakfast briefing on Latest CTD and eCTD updates in Egypt & MENA region

Experts from one of the leading eCTD providers will give overview about the eCTD implementation in the region and give forecasts for the next 5 years how the eCDT map...
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Discussion on Universal Health Coverage Law in Egypt and its influence on other MENA countries

A universal health coverage law expanding access to health care in Egypt was approved by parliament in Mid December after years of discussion and planning. Tedros Adhanom, director-general of WHO,...
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11:00 - 11:30

Coffee and Networking Break

Special presentation on Pharmacoeconomics

This session will discuss the development & potential of Pharmacoeconomics in MENA region. The speaker will answer following questions: How Pharmacoeconomics is currently being used What is needed to advance...
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Expert views on Drug Pricing Mechanisms in MENA region and recommendations from industry & government prospective

Pharma industry questions and concerns when it comes to pricing: how the price is calculated, what is the new pricing quotation planned by regulatory bodies, what the guidelines say. Difference...
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13:00 - 14:00

Lunch

Session 3: Discussion on biosimilars – market access and circulation

The increasing availability of biosimilar medicines in Middle Eastern regions may provide an opportunity for patients to have access to traditionally more expensive biologic medicines. However, as well as a...
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Discussion on Investment in modernisation – Implementing new systems to optimize quality aspects

In 2017 we have discussed manufacturing challenges in the MENA region. We have invited Top Egyptian manufacturers to share their experience and we have asked GCC regulators to explain what...
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Session 20:20 Track & Trace as a Solution for Counterfeit

Each year 500,00 people die of malaria annually, a preventable disease. Anti-malarial drugs often don’t work as they are fake or substandard… Could Serialisation be a long term solution to...
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10:00 - 10:30

Coffee Break

13:00 -14:00

Lunch

15:30 - 16:00

Coffee Break

10:30 -11:00

Coffee Break

13:00 - 14:00

Lunch

15:30 - 16:00

Coffee Break