GCC Regulatory Affairs Pharma Summit 2020
Call
1st & 2nd September, 2020

eCTD Training

We want to bring the two groups of players “Industry” and “Authority” together. You work together on submissions along a typical eCTD scenario. During the day you will learn and discuss the needs of your counterparts and achieve a common understanding of the eCTD process. Furthermore, we will offer you the opportunity to use all the tools of the EXTEDO suite:

  • eCtd Training Day 1

    Day 1 – 1st September 2020

  • eCtd Training Day 2

    Day 2 – 2nd September 2020

eCTD Training

Sunday, March 22nd, 2020

09:00 Introduction: “Simulation game eCTD”

09:15 check Starting eSUBmanager / EURSnext
check The elementary terminology of eSUBmanager / EURSnext
check Working on a dossier in eSUBmanager / EURSnext
check Lifecycle filters & Views
check Document Lifecycle
check Follow Applicant’s Hyperlinks
EURS next eSUB manager

10:30 Coffee Break

10:45Use EURSnext to quickly assess deficiencies
EURS next

11:15checkSubmission Lifecycle & M1 Modifications
check Adding Documents (new)
check Filenaming conventions
check Document Lifecycle (add / replace / append)
checkCreate Hyperlinks
eCTDmanager companion for eSUBmanager’s dynamic view
eCTD mangereSUB manager

12:30 Lunch

13:30 check Incremental submission Export
checkValidation, Finish submission
eCTD manager

14:15 Validate Business Rules
EURS validator

14:30 check UUID Import in EURS
check Comparing the reviewing tools in
EURS EURS validator

15:30 Coffee Break

15:45 check Business case “Document Comparison” in EURS / eSUBmanager / EURSnext
check Search, Favourites
eSUB managerEURS nextEURS

16:45 17:00 checkFinal questions
check Closing

Day 1 – 1st September 2020

09:45 - 10:00 Login and Registration

10:00 - 11:00 Introduction
1. The history of eCTD & Global acceptance
2. The eCTD structure & workflow
3. Q&A
by Michael Faust, Business Consultant RCC, EXTEDO, Germany

11:00 - 12:00 eCTD Basics
1. The "e" in eCTD
2. Bookmarks & Hyperlinks
3. Technical files & XML Backbone The GCC M1 Envelope
4. Q&A
by Michael Faust, Business Consultant RCC, EXTEDO, Germany

12:00 - 13:00 Lunch Break

13:00 - 13:40 Requirements for eCTD and how to make yourself and your documents eCTD-ready
1. Pre-Conditions
2. Document Templates
3. Document Publishing
4. eCTD publishing
5. Best Practice
4. Q&A
by Asmaa Khalil, MENA RA Manager, Boston Biopharma Ltd, Malta

13:40 - 15:00 Lifecycle Management
1. Document Lifecycles
2. Lifecycle - from a sequence perspective
3. Regulatory Activities
4. Q&A
by Michael Faust, Business Consultant RCC, EXTEDO, Germany

15:00 End of Day 1

Day 2 – 2nd September 2020

09:45 - 10:00 Login

10:00 - 11:15 Validation and GCC specifics
1. eCTD Validation
2. GCC Validation Rules
3. GCC Specifics & Updates
4. Best Practice - Hints & Pitfalls
5. Q&A
by Michael Faust, Business Consultant RCC, EXTEDO, Germany

11:15 - 12:00 The Drug Registration in GCC and EU
1. The drug registration pathway in GG
2. Differences to EU drug registration system
3. Q&A
by Asmaa Khalil, MENA RA Manager, Boston Biopharma Ltd, Malta

12:00 - 13:00 Lunch Break

13:00 - 14:00 eCTD Creation Tools
1. Selecting suitable eCTD creation tool
2. The eCTD XML Code in detail (optional)
3. Demonstration: creating an eCTD in a tool
4. Q&A
by Michael Faust, Business Consultant RCC, EXTEDO, Germany

14:00 - 14:45 EXTEDO's Portfolio Overview by Anastasiia Diatchyk, Account Manager, EXTEDO, Germany

14:45 - 15:00 Final Questions

15:00 End of Training

Day 1, Pharmacovigilance training

Tuesday, July 14th, 2020

09:00 - 09:15 Login and Registration

09:15 - 09:25 Welcome & Introduction

09:25 - 09:45 Pharmacovigilance guideline updates in UAE

09:55 - 10:15 Pharmacovigilance system update in KSA

10:25 - 10:45 A snapshot of Pharmacovigilance system in Oman

10:45 - 11:15 Coffee Break

11:15 - 11:35 Pharmacovigilance trends and updates in Kuwait

11:45 - 12:15 Panel Discussion: Feedback from Health Authorities – The role of effective communication and interaction

12:15 - 13:30 Lunch Break

13:30 - 13:50 PV Business continuity Plan- An overview

14:00 - 14:20 Driving and Monitoring effective Quality Management strategies in Pharmacovigilance

14:30 - 14:50 The impact of Artificial Intelligence & Automation in Pharmacovigilance

14:50 - 15:30 Coffee Break

15:30 - 15:50 Drug safety assessment using Dubai Real World Database (DRWD)

16:00 - 16:20 Evaluating the effectiveness of implementation of Additional Risk Minimization Measures in Pharmacovigilance

16:30 - 17:00 Panel Discussion

17:00 Wrap up of Day 1

Day 2, Pharmacovigilance training

Wednesday, July 15th, 2020

08:45 - 09:00 Login and Registration

09:00 - 09:10 Welcome & Introduction

09:10 - 09:30 Tips to be better prepared for Pharmacovigilance inspection

09:40 - 10:00 What do Health Authorities expect from the Industry?

10:00 - 10:30 Coffee Break

10:30 - 10:50 Workshop: Writing an effective Corrective and Preventive Actions (CAPAs) plan

10:50 - 12:00 Q & A

12:00 - 13:00 Lunch Break

13:00 - 13:20 Transforming Pharmacovigilance through Patient Centricity

13:30 - 13:50 Real-life Experiences: Patients awareness and involvement

13:50 - 14:15 Coffee Break

14:15 - 14:35 Patient Support Programs – What does the future hold?

14:35 - 15:15 Q & A

15:15 Wrap up of Day 2 & Close of Training

Speakers

Michael Faust

Business Consultant RCC, EXTEDO, Germany

Michael studied and graduated in Biology, focusing on neurobiology and working in the neuroanatomical research field.

In 2017 he joined EXTEDO as a Junior Business Consultant, where he work in the Regulatory Competence Center since then. He provides software trainings and business consulting internationally, internal and external support as well as tracking regulatory updates on registration procedures globally.

Asmaa Khalil

MENA RA Manager, Boston Biopharma Ltd, Malta

Asmaa Khalil is manager of MENA RA at Boston Biopharma Limited. She has more than 15 years’ experience in global regulatory affairs “Africa, CIS, America, EU & APAC”.

Asmaa is expert consultant in CTD, NeeS & eCTD compilation and submission of dossiers. She was the speaker of more than 30 worldwide workshops relevant to pharmaceutical industry and CTD\eCTD sessions.

Asmaa earned her B.S. in Pharmaceutical Sciences from Cairo University, and her M.Sc. in Biochemistry.

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