GCC Regulatory Affairs Pharma Summit 2020
Call

Conference & Training Schedule

  • eCTD Training

    Sunday, March 22nd, 2020

  • Day 1, GCC Regulatory Affairs Pharma Summit

    Wednesday, July 22nd, 2020

  • Day 2, GCC Regulatory Affairs Pharma Summit

    Thursday, July 23rd, 2020

  • Day 1, Pharmacovigilance training

    Tuesday July 14th, 2020

  • Day 2, Pharmacovigilance training

    Wednesday July 15th, 2020

eCTD Training

Sunday, March 22nd, 2020

09:00 Introduction: “Simulation game eCTD”

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10:30 Coffee Break

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12:30 Lunch

13:30 check Incremental submission Export
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14:15 Validate Business Rules
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15:30 Coffee Break

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Day 1, GCC Regulatory Affairs Pharma Summit

Wednesday, July 22nd, 2020

08:00 – 09:00 Registration and Morning Coffee

09:00 – 09:05 Welcome Address

09:05 – 09:25 Inauguration and Keynote Presentation

09:25 – 10:45 Session 1 - Emerging regulatory updates in the pharma market in GCC countries

10:45 – 11:15 Q & A and Discussion Panel

11:15 – 11:45 Coffee & Networking Break

11:45 – 12:05 Expert View - Recommendations to tackle the bottlenecks in regulations (timeline, resources and process)

12:05 – 12:45 Regulatory requirements and the benefit of keeping ahead of regulations

12:45 – 13:00 Q & A

13:00 – 14:00 Lunch and Networking Break

14:00 – 14:40 Session 2 - Gulf Standard Serialization - Snapshot of the latest information in GCC

14:50 – 15:20 Discussion Panel

15:20 – 15:30 Q & A

15:30 – 16:15 Discussion: An industry perspective on the need for a comprehensive system for Serialization

16:15 – 16:30 Q & A

16:30 – 17:30 Roundtable Discussion and Afternoon Tea

17:30 Close of Day 1

Day 2, GCC Regulatory Affairs Pharma Summit

Thursday, July 23rd, 2020

08:30 – 09:00 Registration and Coffee

09:00 – 09:30 New European Guidelines affecting GCC

09:30 – 10:10 Session 3 – Protecting Intellectual Property (IP) in Pharma

10:10 – 10:45 Discussion: The need for a strong, modern and unified IP system

10:45 – 11:15 Networking & Coffee Break

11:15 – 11:45 GCC Central Drug Registration: Streamlining regulations, procedures and pricing whilst maintaining safety and efficacy

11:45 – 12:25 Session 4 - The North African file on Regulations in Pharma in Alegria and Morocco

12:25 – 13:00 Discussion Session

13:00 – 14:00 Networking & Lunch

14:00 – 14:40 Session 5 - Regulations on GxP - GMP, GLP, GDP, GCP

14:40 – 14:50 Q & A

14:50 – 15:10 Compounding Pharmacy regulations in UAE / Rare pharma regulations in UAE

15:10 – 15:30 The Regulatory Intelligence – Adoption of Artificial Intelligence (AI) in pharma

15:30 - 16:00 Coffee & Networking Break

16:00 Close of Summit

Day 1, Pharmacovigilance training

Tuesday July 14th, 2020

09:00 - 09:15 Welcome & Introduction

09:15 - 09:35 Pharmacovigilance guideline updates in UAE

09:35 - 09:55 Pharmacovigilance system update in KSA

09:55 - 10:15 A snapshot of Pharmacovigilance system in Oman

10:15 - 11:15 Coffee Break

11:15 - 11:45 Pharmacovigilance trends and updates in Kuwait

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

12:15 - 13:30 Group Photo & Lunch

13:30 - 14:15 Transforming Pharmacovigilance through Patient Centricity

14:15 - 15:00 Real-life Experiences: Patients awareness and involvement

15:00 - 15:30 Coffee Break

15:30 - 16:30 Patient Support Programs – What does the future hold?

16:30 - 17:00 Q & A

17:00 Wrap up of Day 1

Day 2, Pharmacovigilance training

Wednesday July 15th, 2020

09:00 - 09:15 Welcome & Introduction

09:15 - 10:00 Tips to be better prepared for Pharmacovigilance inspection

10:00 - 10:30 What do Health Authorities expect from the Industry?

10:30 - 11:00 Coffee Break

11:00 - 11:45 Workshop: Writing an effective Corrective and Preventive Actions (CAPAs) plan

11:45 - 12:00 Q & A

12:00 - 13:00 Lunch Break

13:00 - 13:45 Driving and Monitoring effective Quality Management strategies in Pharmacovigilance

13:45 - 14:30 The impact of Artificial Intelligence & Automation in Pharmacovigilance

14:30 - 15:00 Coffee Break

15:00 - 15:30 Drug safety assessment using Dubai Real World Database (DRWD)

15:30 - 16:00 Evaluating the effectiveness of implementation of Additional Risk Minimization Measures in Pharmacovigilance

16:00 - 16:30 Discussion Panel

16:30 Wrap up of Day 2 & Close of Training

Download Agenda