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Good Manufacturing Practices in Malaysia
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Ershad Moradi

Content Marketing Specialist

Good Manufacturing Practices in Malaysia: GMP Requirements and Compliance in 2026

In Malaysia, GMP compliance works as lifecycle-based regulatory oversight, not a simple checklist. Regulators assess quality system maturity, risk control, and day-to-day process control across the full production lifecycle. Therefore, manufacturers must align operations, staff competence, and documentation with inspection expectations to protect patient safety and supply reliability.
  • Blog, Compliance, GMP, Quality Assurance
Career Change in Pharma_ Real Entry Paths and Roles in 2026
Picture of Mahtab Shardi

Mahtab Shardi

Career Change in Pharma: Real Entry Paths and Roles in 2026

Career change in pharma has become increasingly common as the pharmaceutical industry expands far beyond traditional laboratory-based roles. Recent workforce data from Europe and North America show that more than 40%...
  • Career Development
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Stephanie Maennicke

Digital Marketing Especialist

ICSR in Pharmacovigilance: Meaning & Validity 

An ICSR in pharmacovigilance is more than a safety “message.” It is a structured report that links an identifiable patient, an identifiable reporter, a suspect medicinal product, and an adverse event/reaction—the four minimum criteria used to confirm case validity.
  • Career Development, Pharmacovigilance
Quality Management Pharma Course
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Mahtab Shardi

Quality Management Pharma Course: A Practical Guide to Pharmaceutical Quality Systems in 2026

This practical course guide explains how pharmaceutical quality systems work in real GMP settings. You learn core QMS elements, documentation rules, and inspection expectations. You also explore CAPA, deviations, change control, and risk management, so you build audit-ready habits fast.
  • Blog, GMP, QMS, Regulatory
Dechallenge
Picture of Ershad Moradi

Ershad Moradi

Content Marketing Specialist

Dechallenge in Pharmacovigilance: Meaning, ADR Causality, and ICSR Documentation

Dechallenge is what you observe after stopping a suspected medicine. If symptoms improve, you gain supportive evidence for causality assessment. However, improvement alone does not prove the drug caused the event. So, document drug action, dates, and outcomes clearly. Then compare with rechallenge, which can strengthen causality when safe and justified.
  • Blog, Compliance, Pharmacovigilance
rechallenge in pharma
Picture of Ershad Moradi

Ershad Moradi

Content Marketing Specialist

Rechallenge in Pharmacovigilance: Meaning, Positive Rechallenge, and ICSR Reporting

Rechallenge in pharmacovigilance helps you assess causality when symptoms recur after re-exposure. This guide explains meaning, where to record outcomes in an ICSR, and how to judge validity. It also shows why clear timelines and dose details protect patients. Strong documentation also builds your Pharmacovigilance Career Path through better case quality.
  • Blog, Compliance, Pharmacovigilance
validation during routine production
Picture of Ershad Moradi

Ershad Moradi

Content Marketing Specialist

Concurrent Validation in Pharma 2026 Guide: Meaning, Acceptance, and Execution Steps

Concurrent validation in pharma lets you verify a process while you manufacture saleable batches. Use it only when you face real supply urgency and you can’t wait for prospective validation. Build a risk-based protocol, tighten controls, and document every decision for inspection readiness.
  • Blog, Compliance, CSV, GMP, Validation
pharmaceutical analytical method development (
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Mahtab Shardi

Method Validation in Pharma: 5 Steps to Accurate, GMP-Compliant Results in 2026

Method Validation in Pharma proves your analytical results stay accurate and GMP-ready in [year. First, you define scope, risk, and acceptance criteria. Then, you confirm specificity, accuracy, precision, and linearity. Next, you set LOD/LOQ and verify robustness under small method changes. Finally, you document everything for audits and stronger scientific rigor.
  • Blog, Compliance, GMP, Quality Assurance
Picture of Mahtab Shardi

Mahtab Shardi

CIOMS in Pharmacovigilance: A Complete 2026 Guide

CIOMS guidelines help pharmacovigilance teams report, assess, and share safety data consistently. They support clear case processing, signal detection, and periodic reporting across regions. Use CIOMS forms and standards to reduce errors, align with regulators, and improve patient safety decisions.
  • Blog, Pharmacovigilance, Project Management, Regulatory
Market Access in pharma
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Mahtab Shardi

Market Access Pharma Courses: Skills, Frameworks & Real-World Applications (2026 Guide)

Market access decides whether patients can actually get a medicine. So, it blends value evidence, pricing logic, reimbursement, and stakeholder alignment. In this blog, you will learn the core market access skills, the main frameworks used in pharma, and how teams apply them in real launches. You will also see how HEOR, payer needs, and local policy rules shape access decisions. Finally, you will learn how structured Market Access Pharma Courses turn theory into practical, job-ready capability.
  • Blog, Project Management, Regulatory, Technology