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Quest Training

Pharmaceutical Regulatory Affairs & Compliance Training Course

Guides regulatory teams through pharmaceutical compliance across the product lifecycle, from registration and manufacturing to post-market surveillance.

PMS · Pharmaceutical & Medical Supply ManagementAll Levels#2614ClassroomEnglish , Arabic
Duration
5 Days
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Free substitution at any time · 30+ days' notice: full refund minus 10%. Cancellation policy

Sectors:Healthcare & Hospital ManagementCategories:Pharmaceutical & Medical Supply Management

Course Overview

This advanced programme provides a practical framework for managing pharmaceutical regulatory affairs and compliance throughout the product lifecycle. It focuses on the regulatory requirements governing pharmaceutical products from development and registration through manufacturing, distribution, post-market surveillance, variations, renewals, and product discontinuation. The programme examines regulatory strategy, registration pathways, dossier preparation, regulatory submissions, authority interactions, product information, labelling, promotional compliance, and regulatory change management. It also addresses the coordination required between regulatory affairs, quality, manufacturing, medical affairs, pharmacovigilance, supply chain, and commercial functions. Participants will develop practical approaches for maintaining regulatory compliance, managing submissions and commitments, responding to regulatory authority requests, controlling product changes, and identifying compliance risks. Particular attention is given to documentation quality, submission timelines, regulatory intelligence, inspection readiness, and maintaining accurate product information. Through regulatory case studies, submission exercises, compliance scenarios, change assessments, and authority-response simulations, participants will strengthen their ability to manage regulatory obligations efficiently and support compliant pharmaceutical operations.

Learning Objectives

  • Analyse the role and responsibilities of pharmaceutical regulatory affairs across the product lifecycle.
  • Interpret key regulatory requirements affecting pharmaceutical products and operations.
  • Develop regulatory strategies for product registration and market entry.
  • Apply structured approaches to regulatory dossier preparation and submission.
  • Manage regulatory authority communications, queries, and commitments.
  • Evaluate regulatory implications of pharmaceutical product and process changes.
  • Strengthen compliance controls for labelling, product information, and promotional materials.
  • Apply regulatory requirements to variations, renewals, transfers, and post-approval activities.
  • Identify regulatory compliance risks and develop appropriate mitigation measures.
  • Strengthen coordination between regulatory affairs, quality, pharmacovigilance, manufacturing, and commercial teams.
  • Apply regulatory intelligence to anticipate changes and support business decisions.
  • Develop practical systems for monitoring regulatory obligations and maintaining continuous compliance.

Who Should Attend

Regulatory Affairs Managers and Specialists Pharmaceutical Compliance Managers Regulatory Submission Professionals Quality Assurance and Quality Compliance Professionals Pharmaceutical Product Managers involved in regulatory activities Pharmacovigilance Professionals Medical Affairs Professionals Pharmaceutical Manufacturing and Quality Professionals Regulatory Project Managers Pharmaceutical Legal and Compliance Professionals Professionals responsible for product registration and lifecycle management Professionals preparing to assume regulatory affairs responsibilities

Learning Outcomes

  • Explain the regulatory affairs function and its role throughout the pharmaceutical product lifecycle.
  • Analyse regulatory pathways and requirements for pharmaceutical product registration.
  • Structure regulatory submission activities and documentation effectively.
  • Review key components of pharmaceutical regulatory dossiers.
  • Manage regulatory authority interactions, questions, and submission commitments.
  • Assess regulatory consequences of product, manufacturing, and process changes.
  • Manage variations, renewals, transfers, and other post-approval regulatory activities.
  • Evaluate labelling, product information, and promotional materials for regulatory compliance.
  • Identify regulatory compliance gaps and develop corrective actions.
  • Coordinate regulatory requirements with quality, pharmacovigilance, manufacturing, and commercial functions.
  • Use regulatory intelligence to monitor emerging requirements and assess their impact.
  • Develop an integrated pharmaceutical regulatory compliance framework.

Course Outline

Day 1

Pharmaceutical Regulatory Affairs & Regulatory Strategy

  • Role and scope of pharmaceutical regulatory affairs
  • Regulatory lifecycle of pharmaceutical products
  • Regulatory authorities and stakeholder responsibilities
  • Regulatory pathways and market-entry strategies
  • Product classification and regulatory considerations
  • Regulatory planning during product development
  • Registration strategy and submission planning
  • Regulatory intelligence and monitoring
  • Regulatory timelines and critical milestones
  • Cross-functional regulatory governance
  • Regulatory risk identification and prioritisation
  • Practical Application: Develop a regulatory strategy and submission roadmap for a pharmaceutical product
Day 2

Regulatory Submissions, Dossiers & Authority Interactions

  • Structure and purpose of pharmaceutical regulatory dossiers
  • Common technical documentation principles
  • Administrative, quality, non-clinical, and clinical information
  • Submission preparation and document control
  • Submission lifecycle and regulatory tracking
  • Managing regulatory authority questions
  • Preparing responses to deficiencies and requests for information
  • Regulatory commitments and correspondence management
  • Submission quality and consistency controls
  • Electronic submission considerations
  • Regulatory meeting preparation and authority communication
  • Practical Application: Review a simulated regulatory submission and develop responses to authority questions
Day 3

Post-Approval Changes, Variations & Product Lifecycle Management

  • Principles of post-approval regulatory management
  • Variations and change classification
  • Manufacturing and process changes
  • Changes to specifications, suppliers, facilities, and packaging
  • Labelling and product information updates
  • Regulatory impact assessment
  • Renewal and re-registration requirements
  • Product transfers and ownership changes
  • Managing regulatory commitments after approval
  • Product discontinuation and regulatory closure
  • Change control coordination with quality and manufacturing
  • Practical Application: Conduct a regulatory impact assessment for a proposed pharmaceutical product change
Day 4

Pharmaceutical Compliance, Promotional Controls & Risk Management

  • Regulatory compliance frameworks
  • Compliance responsibilities across pharmaceutical functions
  • Product information and labelling requirements
  • Promotional and medical communication compliance
  • Scientific claims and supporting evidence
  • Managing compliance risks in commercial activities
  • Regulatory documentation and records management
  • Inspection readiness and regulatory audits
  • Compliance deviations and corrective actions
  • Escalation and regulatory risk reporting
  • Coordination with quality, pharmacovigilance, medical, and legal functions
  • Practical Application: Assess a simulated promotional or product-information package for regulatory compliance risks
Day 5

Regulatory Intelligence, Governance & Integrated Compliance

  • Regulatory change monitoring
  • Assessing the business impact of new regulatory requirements
  • Regulatory intelligence sources and analytical approaches
  • Building regulatory obligations registers
  • Compliance calendars and regulatory tracking systems
  • Key regulatory performance indicators
  • Regulatory risk dashboards and management reporting
  • Cross-functional regulatory governance
  • Preparing for regulatory inspections and authority interactions
  • Continuous improvement of regulatory processes
  • Building a sustainable regulatory compliance culture
  • Final Workshop: Develop an integrated Pharmaceutical Regulatory Affairs & Compliance Plan covering registration strategy, submissions, authority interactions, post-approval changes, labelling, promotional compliance, regulatory intelligence, risk management, and continuous compliance.

Upcoming Dates

Selected date

Bangkok · 2 – 6 Nov 2026 · Classroom

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CityDatesPrice per ParticipantEarly Bird
DohaScheduled
2 – 6 Nov 2026€4,400—
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BangkokScheduled
2 – 6 Nov 2026€6,100—
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DubaiScheduled
8 – 12 Nov 2026€4,400—
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GenevaScheduled
16 – 20 Nov 2026€6,300—
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BeirutScheduled
22 – 26 Nov 2026€4,000€3,600until 2 Nov
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IstanbulScheduled
23 – 27 Nov 2026€4,700€4,230until 2 Nov
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JeddahScheduled
29 Nov – 3 Dec 2026€4,200€3,780until 9 Nov
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CairoScheduled
6 – 10 Dec 2026€3,300€2,970until 16 Nov
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Kuala LumpurScheduled
7 – 11 Dec 2026€4,400€3,960until 16 Nov
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LondonScheduled
14 – 18 Dec 2026€5,600€5,040until 23 Nov
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LisbonScheduled
14 – 18 Dec 2026€5,400€4,860until 23 Nov
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MadinahScheduled
21 – 25 Dec 2026€4,200€3,780until 30 Nov
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MadridScheduled
28 Dec 2026 – 1 Jan 2027€5,400€4,860until 7 Dec
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Cape TownScheduled
28 Dec 2026 – 1 Jan 2027€5,100€4,590until 7 Dec
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MakkahScheduled
4 – 8 Jan 2027€4,200€3,780until 14 Dec
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ManamaScheduled
11 – 15 Jan 2027€4,700€4,230until 21 Dec
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MarbellaScheduled
18 – 22 Jan 2027€5,400€4,860until 28 Dec
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CasablancaScheduled
18 – 22 Jan 2027€4,300€3,870until 28 Dec
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MarrakeshScheduled
25 – 29 Jan 2027€4,300€3,870until 4 Jan
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MunichScheduled
1 – 5 Feb 2027€5,400€4,860until 11 Jan
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MilanScheduled
1 – 5 Feb 2027€6,000€5,400until 11 Jan
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DammamScheduled
7 – 11 Feb 2027€4,200€3,780until 18 Jan
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MuscatScheduled
8 – 12 Feb 2027€5,300€4,770until 18 Jan
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OnlineScheduled
14 – 18 Feb 2027€1,700€1,530until 25 Jan
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ErbilScheduled
21 – 25 Feb 2027€3,100€2,790until 1 Feb
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ParisScheduled
22 – 26 Feb 2027€5,700€5,130until 1 Feb
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RabatScheduled
1 – 5 Mar 2027€4,300€3,870until 8 Feb
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RiyadhScheduled
8 – 12 Mar 2027€4,200€3,780until 15 Feb
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ViennaScheduled
15 – 19 Mar 2027€5,700€5,130until 22 Feb
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FrankfurtScheduled
15 – 19 Mar 2027€5,800€5,220until 22 Feb
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Available in: Istanbul · Dubai · London · Riyadh · Doha · Amsterdam

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