Corporate & In-House Custom Trainings

Inspire Pharma Consultancy provides customised, on-demand training programmes tailored to the specific needs of organisations and companies.

These trainings can be delivered in-house, virtually, or on-site, and are adapted based on company size, product portfolio, regulatory scope, and operational maturity.

We design on-demand trainings to support:

New Team Onboarding
Role-Based Training
Practical Inspection & Audit Preparation
Capability Building & Upskilling
Strengthening Technical & Operational Skills
Targeted PV or Regulatory Gap Closure

Training Topics

Pharmacovigilance

Practical training on end-to-end ICSR processing, quality checks, timelines, and regulatory submission requirements across global markets.

Training on systematic literature screening, signal identification, documentation standards, and regulatory-compliant monitoring processes.

Focused training on safety oversight for clinical trials, Patient Support Programs (PSPs), and Named Patient Programs (NPPs), including reporting workflows and compliance requirements.

Hands-on training on developing and maintaining risk management systems, preparing RMPs, and designing effective risk minimisation measures.

Preparation and submission of periodic safety update reports (PSURs) and development safety update reports (DSURs).

Practical guidance on writing, reviewing, and implementing SOPs, Work Instructions, and Safety Data Exchange Agreements in line with regulatory expectations.

Training on building and maintaining a compliant PV quality management system, including governance, documentation, and continuous improvement.

Training on preparing for PV audits and inspections, covering expectations, documentation, interview readiness, CAPA management, and inspection conduct.

Training on signal detection, validation, assessment, prioritisation, and management of emerging safety issues in alignment with GVP requirements.

Training Topics

Regulatory Affairs

Training on conducting regulatory due diligence, identifying gaps, and assessing readiness for registrations, licensing, or market entry.

Practical sessions on developing product-specific regulatory strategies aligned with regional and global regulatory frameworks.

Training on managing post-approval regulatory activities including variations, renewals, safety updates, and packaging changes.

Hands-on training on eCTD structure, compilation, validation, and submission according to regulatory technical standards.

Training on regulatory and PV-compliant labelling, medical translation, artwork review, and lifecycle labelling updates.

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