Training & Workshops

In the ever-evolving world of pharmaceuticals, staying updated with regulatory changes, documentation standards, and global compliance expectations is not optional—it’s essential.

At DrugRegulatoryAffairs.in, we offer structured, expert-led training programs and customized workshops designed to empower professionals, students, and pharma teams with actionable regulatory knowledge.

Our training modules are crafted by seasoned regulatory affairs professionals with hands-on industry experience, and are updated in line with the latest CDSCO, USFDA, EMA, and ICH guidelines.

🧠 What We Do

We design and deliver online, offline, and in-house training programs tailored to your team’s skill level and organizational needs.

Whether you’re looking to upskill your regulatory team, train new recruits, or prepare for audits, we have you covered.

📚 Training Topics Offered

📘 Regulatory Affairs Basics

  • Introduction to drug regulatory affairs
  • Role of CDSCO, USFDA, EMA
  • Drug development to approval pipeline

📑 CTD/ACTD Dossier Writing

  • Detailed training on preparing Modules 1 to 5
  • Real-world examples and templates
  • Formatting, compliance, and submission best practices

🧾 Pharmacovigilance (PV)

  • ADR reporting process (CDSCO & global systems)
  • PV system setup and SOPs
  • GVP Module trainings

📄 Clinical Trial Documentation

  • Study protocols, IBs, ICFs, and CRFs
  • CTRI registration
  • Ethics Committee and DCGI requirements

🌍 Global Regulatory Strategies

  • Regulatory filing differences: India vs USFDA vs EMA
  • Country-specific requirements (ASEAN, GCC)
  • Export certification guidance

🏫 Formats Available

  • Live Online Webinars (Zoom/Google Meet)
  • On-Demand Recorded Sessions
  • In-House Corporate Training
  • Academic Training for Pharma Colleges
  • 1-on-1 Mentorship Programs

🧑‍💼 Who Should Attend?

  • Regulatory Affairs professionals and QA/QC teams
  • Pharma company HR teams training recruits
  • Final-year pharmacy students and freshers
  • Biotech entrepreneurs and SMEs entering regulated markets

🏆 Why Choose Our Trainings?

  • Certified trainers with industry-recognized credentials
  • Practical, example-rich sessions (not just theory)
  • Post-training support & consultation
  • Access to downloadable materials and templates
  • Certification of Completion provided