● Enrolment open · Next cohort · January 2027
Think like a regulatory assessor.
From regulatory knowledge to regulatory judgment.
The Applied Regulatory Affairs Certificate (ARAC) is a practical 16-session program that teaches the science behind every requirement, the regulatory logic behind it, and how to review a dossier with confidence.
✓ 16 live online sessions
✓ Review checklist every session
✓ ICH · FDA · EMA · SFDA
Next cohort
January 2027
ARAC · Cohort 1 · Live online
✓
16 interactive live sessions from regulatory thinking to RA leadership
✓
A review checklist and takeaway for every session
✓
The ARAC Integrated Review Method for dossiers, variations and issues
✓
ARAC certificate on completion
11
Core regulatory domains
4
Frameworks: ICH, FDA, EMA, SFDA
840+
APA Academy graduates across MENA
180+
Companies APA graduates work at
APA Academy graduates work at more than 180 companies across the MENA region
Who it's for
Built for the people who carry products to approval.
For regulatory affairs, quality and development professionals in the Middle East who want to move from collecting documents to making evidence-based regulatory decisions.
ARAC's philosophy: don't memorize requirements in isolation. Understand why each requirement exists, what risk it controls, what evidence supports it and how the conclusion affects the patient.
01
Regulatory Affairs Specialists
Strengthen dossier review, variations and authority responses with a structured method.
02
Quality, R&D & Analytical Professionals
Connect your technical work to the regulatory story the authority will read.
03
Pharmacists & Scientists Entering RA
Build the scientific and regulatory foundation to start a career in regulatory affairs.
Your learning journey
Science. Strategy. Application.
Every ARAC session combines the scientific basis, the regulatory logic behind the requirement, the questions an assessor should ask and a concise review checklist.
01 · Learn
16
Interactive live sessions
Regulatory pathways, CTD, QbD, DMF review, analytical validation, specifications, nitrosamines, stability, bioequivalence and biosimilars.
02 · Apply
8 steps
Integrated review method
Apply one repeatable sequence to any product, dossier, variation or regulatory issue, from defining the question to documenting a reproducible decision.
03 · Lead
10 KPIs
RA starter dashboard
Design an RA department and build KPIs that measure regulatory value, predictability and compliance, not activity alone.
How you'll learn
Learn regulatory affairs the way assessors think.
ARAC is built around evidence chains: link every claim to evidence, the evidence to an accepted standard, and the standard to the patient or product risk it controls.
Live & online
Interactive sessions built on real regulatory questions
Review checklists
A practical checklist for every session
Red-flag training
Spot the issues that should trigger a deeper review
Direct instructor access
Fast, personal support via WhatsApp
ARAC learning objectives
16 sessions. One connected way of thinking.
By the end of ARAC, you'll review a product, dossier or variation as one connected evidence story, across quality, bioequivalence, biosimilars and regulatory leadership.
Sessions 1–2 · Foundations
Regulatory Thinking & Intelligence
◆ Differentiate compliance from regulatory thinking
◆ Select the right regulatory pathway
◆ Build reproducible public-domain intelligence
Session 3 · Dossier
Patents & CTD 101
◆ Separate patents from regulatory exclusivity
◆ Navigate the CTD as one evidence system
◆ Trace a claim across CTD modules
Session 4 · Development
Quality by Design Strategy
◆ Connect QTPP, CQAs, CMAs and CPPs
◆ Use risk assessment and design space
◆ Link development data to the control strategy
Session 5 · API
DMF Open-Part Review
◆ Review API route, controls and impurities
◆ Assess supplier and change risk
◆ Find gaps that affect the product dossier
Session 6 · Analytical
Analytical Method Validation
◆ Distinguish development, qualification and validation
◆ Interpret validation characteristics by intended use
◆ Apply orthogonal evidence
Sessions 7–8 · Specifications
Drug Product Specification Setting
◆ Link tests and limits to CQAs and capability
◆ Apply impurity thresholds correctly
◆ Justify specification and dissolution changes
Session 9 · Risk
Nitrosamine Risk Assessment
◆ Map formation and contamination pathways
◆ Run a risk-based assessment workflow
◆ Set acceptable-intake-based limits
Session 10 · Stability
Stability Strategy & Data
◆ Design a stability strategy for shelf life
◆ Interpret trends, variability and statistics
◆ Judge bracketing, matrixing and pooling
Sessions 11–13 · Bioequivalence
Conventional & Non-Conventional BE
◆ Review BE design, conduct and PK endpoints
◆ Handle variability, biowaivers and PBPK
◆ Assess locally acting and topical products
Sessions 14–15 · Biosimilars
Biosimilar Similarity & Dossiers
◆ Structure an analytical similarity assessment
◆ Review the totality of evidence
◆ Distinguish biosimilarity from interchangeability
Session 16 · Leadership
RA Department & KPIs
◆ Design an RA structure for your portfolio
◆ Clarify roles, interfaces and governance
◆ Build KPIs that measure regulatory value
Get the full course outline
Session-by-session objectives, review checklists and takeaways.
Request on WhatsAppFAQ
Questions before you apply?
Can't find your answer here? Message us directly and we'll help you choose the right path.
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How is ARAC delivered?
ARAC runs as 16 interactive live online sessions. Each session combines the scientific basis, the regulatory logic behind the requirement, the questions an assessor should ask and a concise review checklist. The full schedule for the January 2027 cohort is shared on enrolment.
Who is ARAC for?
Regulatory affairs specialists; quality, QC, R&D and analytical professionals; and pharmacists or scientists who want to start or grow a career in regulatory affairs.
Do I need regulatory experience?
No. The first sessions build the foundations: regulatory thinking, pathways, public-domain intelligence and the CTD. Experienced professionals get the most from the advanced sessions on bioequivalence, biosimilars and RA leadership.
Which regulations and guidelines does ARAC cover?
ICH quality guidelines (Q1, Q2, Q3, Q6, Q8, Q9, Q10, Q12 and M7); SFDA, EMA and FDA guidance on bioequivalence, biowaivers and biosimilars; and CTD/eCTD requirements. Sessions always refer to the current version of each guideline.
Will I receive a certificate?
Yes. Participants who complete the program receive the Applied Regulatory Affairs Certificate (ARAC) from APA Academy.
Your regulatory judgment starts in
January 2027.
Seats are limited to keep sessions interactive and discussions practical. Message us to reserve yours.