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Basics of Drug Regulatory Affairs – SFDA System Explained Training 22/12/2020

Details

Date:
22 December، 2020
Time:
9:00 am - 5:30 pm
FEES SAUDI RIYAL
REGISTRATION FEES SAR 1500.00
EARLY BIRDS REGISTRATION FEE PAY YOUR FEE BEFORE                      17th December, 2020. SAR 1000.00

OVERVIEW

Understanding drug regulatory affairs in the GCC region is very important for persons working in pharmaceutical sector in the region. This course is specifically designed for persons working in the regulatory affairs departments or related fields, who need knowledge of the SFDA  regulatory processes. This training will also enhance understanding and be beneficial to persons who work in clinical research, data management, basic research, project management and marketing, etc.

Download Basics of Drug Regulatory Affairs Brochure 22 December 2020

LEARNING OBJECTIVES

At the conclusion of this training, participants will be able to:

  • Define the key principles and processes used by the Saudi Food and Drug Authority (SFDA) in regulatory submission and approval.
  • Define official regulatory policies and other issues pertinent to a successful SFDA  regulatory strategy
  • Describe key differences between National and the Gulf Cooperation Council Drug Registration (GCC_DR) regulatory requirements.
  • Describe the requirements for marketing applications for drugs and biologics, New Drug Application (NDA), Biosimilares, Generic drugs, herbal and health products and document preparation.
  • Recognise SFDA oversight and processes during the post-approval phase.
  • Interact appropriately with the SFDA during all phases of drug registration
  • Understand the regulatory requirements for prescription drug labelling and advertising/promotion.

 

KEY TOPICS

  • Principals of Regulatory Affairs (RA) and Legal Framework
  • SFDA overview and pharmaceutical institutions licensing
  • Principles of Products licensing and Evaluation
  • GMP Inspection and Products Pricing
  • Overview of the pharmacovigilance system
  • Principles of Products Classifications and Listing
  • Products Import, Release and Advertising
  • Overview of the SFDA Electronic systems

 

WHO WILL ATTEND

Professionals working in:

  • Pharma Regulatory Affairs
  • Fresh Graduate
  • Scientific Office Managers
  • Regulatory Authorities.
  • Dossier Management
  • Pharmacist
  • Compliance
09:00 – 10:30 SESSION 1

Principals of Regulatory Affairs (RA) and Legal

Framework

  • The history and evolution of the regulatory authorities

and profession.

  • Principles of Regulatory Affairs and regulatory professional
  • Basic terms and definitions.
  • Legal Framework for Pharmaceuticals regulations.
  • SFDA Law.
  • Pharmaceuticals Institutions and Preparations Law.
  • Principles of pharmaceutical preparations registrations.
  • International Council for Harmonization (ICH) guidelines.
  • Narcotics and psychotropic law.
10:30 – 11:00: COFFEE BREAK

11:00 – 12:30 SESSION 2

Principles of Products licensing and Evaluation

  • ABC for pharmaceutical products licensing.
  • Regulatory Framework for Drug Approvals V_5 0.
  • Guidance for Submission V_4 0.
  • General requirements for pharmaceuticals preparations registration.
  • Principles of pharmaceutical preparations registrations.
  • Common Technical Document (CTD) and eCTD.
  • Pharmaceutical preparations evaluation process.
  • Registration Committees.
  • Product Variations Guidance.
12:30 – 13:30 LUNCH

13:30 – 15:00 SESSION 3

Principles of Products Classifications and Listing

  • Overview of product classifications.
  • Guidance for products classifications.
  • Principles of products listing.
  • Overview of the SFDA Electronic systems.