About the Client
SAVA Healthcare is a growing pharmaceutical organization committed to innovation, global regulatory compliance, and improving healthcare access. With a diversified product portfolio across multiple therapeutic areas, SAVA Healthcare has been actively expanding its international presence, especially in regulated markets. Their core focus includes delivering high-quality, affordable medicines that meet stringent global standards.
Workshop Objective
The training aimed to build a solid foundational and operational understanding of the Drug Approval Process in the EU Market, specifically for teams involved in regulatory, R&D, and quality roles. This hands-on, practical workshop was curated to demystify regulatory pathways, dossier compilation (eCTD/CTD), and lifecycle management of variations, thereby preparing SAVA teams for smoother and faster market entry into the European Union.
Workshop Summary
The session covered the comprehensive regulatory landscape of the EU pharmaceutical market, focusing on approval procedures, lifecycle management, and submission standards. Participants were walked through real-world timelines, documentation formats, and strategic considerations that impact drug development and approvals.
Key focus areas included:
- Strategic planning of regulatory pathways (CP, DCP, MRP, NP)
- Preparing and submitting compliant dossiers using the Common Technical Document (CTD) format
- Understanding variations and their classification: Type IA, IB, II, and Extension Applications
- Leveraging regulatory science and agency interactions to reduce time-to-market
- Mastery over submission portals (EMA Gateway, CESP) and their technical nuances
- Role Clarity and Collaboration: Reinforced the roles of QA, IT, Engineering, and Operations in ensuring validation compliance.
Workshop Details
- Mode: On-Site
- Audience: Regulatory Affairs, QA, R&D, Product Development Teams
- Batch Size: 20 Participants
- Duration: 1-day Workshop
- Customized Training Modules
- Certificates for all participants
Trainer (Speaker) Profile
- A pharmaceutical regulatory expert with over 20 years of technical and leadership experience as Executive Director of a consulting firm specializing in global drug registrations.
- Specializes in CTD/Dossier preparation, DMF (Type II, III, IV) and COS documentation, and successful submissions for APIs, excipients, and finished formulations across regulated markets.
- Has led 100+ training programs on US DMF, COS filing, and regulatory lifecycle management, and is experienced in handling regulatory queries, post-submission deficiencies, and ICH Q7A compliance.
- Provides end-to-end support for BE studies, toxicity/clinical trials (Phase II–IV), on-site GMP training, method validations, and technology transfers, with studies conducted at EU/US-audited facilities.
