Check a dilution calculation
Convert units, check the required aliquot or calculate a mass for solution preparation.
Open the calculator →AUPAM · THE EXPERTS’ OFFICE
A question in your pharmaceutical work?
Start with a practical step.
Source-linked guides, training cases and regulatory news. Choose what you need and start in English or Arabic.
Start with public references and tools. Member workspaces and some training materials require sign-in. How do I use this site?
Recent additions and source-monitoring status
Rooted in the Arab region.
Connected to pharmaceutical practice worldwide.
Union established 1986Office established 3 May 2026
WORK TOOLS · NO SIGN-IN REQUIRED
Bring a work question. Leave with a review copy.
Analyse a temperature log
Import a CSV log. Review excursions, recording gaps and an exportable report.
Try a sample log →Organise an authority response
Turn each question into evidence, actions, responsibilities and a review copy.
Open the response planner →Where should you start?
Three practical packs for your work
Quality and manufacturing
Start with a work question and identify the evidence needed before deciding.
Start with the task and referencesRegulatory affairs and registration
Identify the market and authority, then turn the question into evidence needs and decisions.
Start with the task and referencesMedical devices and supplies
Start with intended purpose and market, then organise safety and performance questions.
Start with the task and referencesFrom source to practice
Prepare your scientific review with clear steps
16 guides across quality, manufacture, registration, safety and research, with scope, source versions and saveable working checklists.
01 / YOUR STARTING POINT
A clearer route to your next step.
Choose your field. Start with a practical task.
From a problem to evidence and action
Connect requirements to the dossier in front of you
Plan a regulatory response
Map each authority question to an action, evidence, owner and review.
Start here →Practise medicines border inspectionCases covering documentation, storage and the cold chain.
Start here →Follow regulatory changesCheck source dates, document status and related deadlines.
Start here →Start with the right source for your question
Frame a clear question, then assess the evidence
Learn the foundation, then apply it to a case
Choose a pharmacy subject
From foundational sciences to industry, practice and research.
Start here →Practise your reasoningCases connecting knowledge with investigation, evidence and decisions.
Start here →Find a workshop or eventThe current office workshop, followed by selected regional and international events.
Start here →02 / THE WORKBENCH
Less searching. More doing.
Open a tool, or pin it here for your next visit.
Pins stay in this browser.
Review
Certificate & evidence review
Check certificate scope, results and batch traceability.
Planner
Regulatory response planner
Turn authority questions into actions, evidence and responsibilities.
Research
Research & evidence desk
Frame your question and organise the evidence behind your work.
Quality
Contamination control strategy
Explore the Office’s contamination control resources.
Development
Bioequivalence & biowaivers
Explore study planning and biowaiver resources.
Training
Medicines border inspection
Practise reviewing documents, storage and cold-chain evidence.
Training
Problem Lab
Practise investigation and decisions through pharmaceutical cases.
Learning
Qualified Person learning
Explore the diploma materials and assessment pathways.
Quality
Stability & climatic zones
Find resources for stability studies and climatic conditions.
Practice
Pharmacy practice
Find medicines information and practice references.
Safety
Medicines safety
Explore pharmacovigilance and medicines safety resources.
Learning
Pharmacy student hub
Connect foundational subjects with practice and research.
Intelligence
Regulatory news centre
Read published updates alongside their original sources.
Learning
Workshops & events
Explore Office training and selected professional events.
References
Complete resource directory
Browse tools, scientific references and learning resources.
Make this your workbench.
Pin the tools you use most with the bookmark button on each card.
MEDICAL DEVICES & SUPPLIES
A dedicated centre for medical technology.
Market pathways, evidence checklists, quality, supply chain, traceability, IVDs, medical software and published safety updates — together in one place.
Open the medical-device centre ↗03 / DATA BANK
The right source. For your question.
Selected global databases and reference pages, with official links and a clear purpose for each.
Orange Book
US-approved drug products, therapeutic equivalence evaluations, patents and exclusivity.
www.fda.govPurple Book
US-licensed biological products, including biosimilars and interchangeable products.
purplebooksearch.fda.govDrugs@FDA
Find US drug approvals, available review documents and labeling.
www.accessdata.fda.govEMA Medicines
Information and assessment reports for medicines evaluated by EMA; not all national authorisations.
www.ema.europa.euWHO Prequalification
Prequalified medicines and assessment resources; prequalification does not replace national registration.
extranet.who.intEudraGMDP
Access manufacturing and import authorisations and GMP/GDP certification records.
www.ema.europa.euICH Quality Guidelines
Quality guidance on stability, impurities, analysis and development. Check each document’s status and version.
www.ema.europa.euInactive Ingredient Database
Inactive ingredients by administration route and dosage form, with official downloadable files.
www.fda.govDailyMed
Current in-use labeling submitted to FDA; listing alone does not establish approval.
dailymed.nlm.nih.govPubMed
Search biomedical literature and abstracts, then follow available full-text links.
pubmed.ncbi.nlm.nih.govClinicalTrials.gov
Search clinical study records and posted results; registration is not proof of an intervention’s effectiveness.
clinicaltrials.govNo matching source. Try another search or choose All.
Directory reviewed: 3 October 2026
Direct reference links; publishers update their data on their own release cycles. Coverage and document status vary by source.
04 / KEEP DEVELOPING
Learn it. Question it. Apply it.
Build the foundation, test it in a case, then apply it at work.
FEATURED OFFICE WORKSHOP
Hands-On LC & LC-MS Workshop
5–7 December 2026 · Amman, Jordan · Face-to-face
With Dr Giles Edwards · In collaboration with Anthias Consulting
Review the programme, trainer and attendance details before registering.All events & training ↗
Regulatory intelligence
News already published by the Office, with its date, source and document status.
Source status & recent additions
Check when sources were last reviewed and what was recently added. Coverage relates to the configured sources.
Recently added to the site
Source date and addition time shown separatelyPublished additions appear here once the record is available.
Arab regulators
Connecting to the update source…
International regulators
Connecting to the update source…
Regulatory actions & safety alerts
Connecting to the update source…
Dates coming up
Connecting to the update source…
THE PEOPLE & THE PURPOSE
Arab expertise.
A wider conversation.
The Experts’ Office is the technical arm of the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances. Its founding board brings experience from regulatory authorities, industry and academia to support product development, manufacturing and registration.
- Regulatory & industrial experience
- Knowledge & practical learning
- Professional & scientific collaboration
Founding members 8 experts
Prof. Dr. Osama Abd Elrahman
Office Chairman & Head of the Scientific Committee
Drug affairs consultant
Dr. Hakima Hoseh
Deputy Chair & Head of the External Affairs and Follow-up Committee
Consultant in regulatory affairs & due diligence
Dr. Mohammad Fat’hy Elnadi
Office Director
Pharma regulatory & business expert
Dr. Anas Alshishani
Financial Advisor
General Manager, PharmaPrime
Dr. Khalid Ahmad Shalaby
Head of the Training Committee
Former General Manager, General Administration of Reference Laboratories, Egyptian Drug Authority
Dr. May Ahmad
Head of the Regulatory Affairs Committee
Expert in biologicals, synthetic peptides and extractables & leachables; former Head of the Biosimilars Unit, Egyptian Drug Authority
Dr. Samah Shawakat
Head of the Quality Management Systems Committee
Medical device expert; former Head of the Diagnostics Unit, Egyptian Drug Authority
Dr. Fouad Darras
Legal Advisor
CEO, Bara’a for Pharmaceutical Patent Consultation
TAKE PART
Bring your question.
Share your expertise.
Explore reference answers, discover the Office’s membership requirements, or get in touch about your professional needs.
From knowledge to practice. From question to source.
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