Managing Global Product Launches for medical devices and pharmaceutical products

Global product launches for medical devices and pharmaceutical products are among the most complex undertakings within the life sciences industry.

Launch success depends on precise coordination of regulatory strategies, technical documentation readiness, manufacturing scale-up, supply chain reliability, marketing alignment, and post-market surveillance capabilities. This webinar provides a comprehensive, highly structured overview of how to plan, implement, and sustain global product launches that meet regulatory requirements while achieving commercial objectives in multiple international markets.

The session begins by framing the complexity of global launches. Attendees will understand how regulatory pathways differ across major markets such as the United States, European Union, United Kingdom, Japan, Canada, and China, and how these timelines must be integrated into an overall launch strategy. Participants also examine the critical differences between pharmaceutical and device launches-such as submission formats, evidence expectations, classification rules, and post-market obligations. The purpose of this segment is to ensure that attendees develop a realistic appreciation for the sequencing, resource demands, and interdependencies inherent in going global.

Next, the webinar explores the development of a global launch strategy that ties regulatory submissions, quality system requirements, clinical evidence generation, and commercial readiness into a unified plan. Participants learn how to assess market attractiveness, identify barriers to entry, and prioritize launch markets based on risk, regulatory feasibility, and commercial opportunity. This section emphasizes cross-functional alignment, demonstrating why regulatory, manufacturing, supply chain, quality, marketing, and customer-facing teams must work together from the earliest phases to avoid downstream bottlenecks.

The regulatory readiness segment delves into both medical device and pharmaceutical-specific requirements, including EU MDR and IVDR demands for clinical evidence and PMS systems, FDA expectations for QMSR/QSR compliance, and global labeling standards such as UDI, serialization, and multilingual packaging. Attendees gain a practical understanding of how to harmonize global technical documentation, manage translations, qualify distribution partners, and maintain vigilance systems capable of supporting all markets.

Operational readiness is addressed from a manufacturing, quality, and supply chain standpoint. Participants learn how to prepare for scaling production, conducting validation studies, ensuring packaging and environmental shipping compliance, and establishing robust supplier oversight. The session also covers the importance of harmonizing QMS documentation, ensuring that procedures, work instructions, and quality records meet the audit expectations of each target market.

Finally, attendees explore how to execute a global launch using structured governance, escalation models, risk management frameworks, and communication plans. The webinar concludes with guidance on sustaining long-term market success by managing post-launch surveillance, complaint handling, re-registrations, and product lifecycle updates.

Why should you Attend:
Participants should attend this webinar because global product launches require exceptional coordination, deep regulatory understanding, and careful planning to avoid costly delays, compliance failures, or market-entry disruptions. Organizations entering multiple international markets face a maze of regulatory pathways, each with unique requirements for clinical evidence, technical documentation, labeling, QMS standards, and post-market reporting. This webinar provides clear, practical guidance that demystifies these complexities and offers actionable strategies for planning a compliant, efficient, and successful global launch.

Attendees will benefit from learning how to build integrated cross-functional launch plans that align regulatory timelines, manufacturing readiness, commercial goals, and quality requirements. The session also equips participants with tools for anticipating and mitigating the most common global launch risks, including regulatory delays, labeling inconsistencies, supply chain disruptions, and inspection findings.

For companies preparing new product introductions-or expanding into new markets-this training offers critical insights into managing documentation, ensuring QMS readiness, and developing strong global operational capabilities. Anyone responsible for regulatory affairs, product management, supply chain, quality assurance, or post-market systems will gain essential knowledge to reduce risk, improve launch performance, and ensure sustainable global success.

Areas Covered in the Session:

• Understanding Global Launch Complexity (10 minutes)
• Define global product launch and contrast medical device vs. pharmaceutical pathways
• Overview of regulatory drivers impacting launch timing (FDA, EMA, MHRA, PMDA, Health Canada, China NMPA)
• Market-entry constraints: labeling, language, post-market, distribution, and supply chain readiness
• Risk factors that often derail global launches
• Webinar goals and expected outcomes
• Building a Global Launch Strategy (10 minutes)
• Conducting global market prioritization and sequencing
• Aligning launch plans with regulatory submission and approval timelines
• Cross-functional alignment across RA, QA, Clinical, Manufacturing, Marketing, and Supply Chain
• Mapping global requirements: device classifications, pharmaceutical approval pathways, dossier requirements
• Identifying and planning for country-specific launch barriers
• Regulatory Readiness for International Markets (10 minutes)
• Device regulations: FDA QSR/QMSR, EU MDR/IVDR, MDSAP requirements
• Pharma regulations: FDA NDA/ANDA/BLA pathways, EMA centralized/decentralized procedures, PMDA processes
• Managing global labeling, UDI, serialization, and translation requirements
• Pre-launch validation, clinical evidence, and technical documentation readiness
• Aligning post-market surveillance and vigilance systems to satisfy global obligations
• Operational, Quality, and Supply Chain Preparation (10 minutes)
• Global demand forecasting and production scaling
• Supplier qualification and distribution network readiness
• QMS alignment, inspection readiness, and documentation harmonization across markets
• Manufacturing readiness: validation, packaging, stability, shipping validations
• IT systems preparation (ERP, QMS, PMS, eIFU, complaint systems)
• Launch Execution, Risk Management & Issue Escalation (10 minutes)
• Launch governance models, roles, and escalation paths
• Managing global launch risks: regulatory delays, supply disruptions, quality issues, and labeling errors
• Communication strategies for internal stakeholders, regulators, and customers
• Integrating change control and CAPA into launch execution
• Monitoring launch performance and real-time corrective agility
• Sustaining Global Market Success Post-Launch (10 minutes)
• Post-launch surveillance and global reporting processes
• Complaint handling and field action readiness
• Maintaining global product lifecycle: updates, re-registrations, and vigilance harmonization
• Strengthening global distribution, commercial operations, and customer support
• Final recommendations and Q&A

• Regulatory Affairs
• Quality Assurance
• Quality Control
• Manufacturing Operations
• Supply Chain / Logistics
• Clinical Affairs / Clinical Operations
• R&D / Engineering
• Marketing & Commercial Operations
• Product Management
• Technical Operations
• Post-Market Surveillance
• Labeling / UDI / Serialization Teams
• Medical Affairs
• Senior Leadership / Program Governance