Prof. Bawazir Pharma Consulting Center

Basics of Drug Regulatory Affairs - SFDA System Explained Training 22/12/2020
2020-12-22 09:00 - 17:30 (Europe/Moscow)
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.
