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Join Top Drug Development Course To Shape Your Career!
This program delivers a complete, structured understanding of the drug development lifecycle, covering every critical stage—from early discovery and preclinical research to clinical trials, regulatory approval, and post-marketing surveillance.
You will explore how drugs are developed, tested, approved, and brought to market, with a strong focus on scientific principles, regulatory requirements, and industry best practices.
Learning Objective
- Drug discovery: target identification, lead optimization, and emerging technologies
- Preclinical development, toxicity studies & pharmacokinetics (ADME)
- Clinical trials (Phase I–III): design, execution & data integrity
- Regulatory pathways (FDA, EMA, global frameworks)
- Biologics vs small molecules: key differences
- Pharmacovigilance & post-marketing surveillance
- Commercialization and lifecycle management strategies
Agenda
Day 1: Drug Development Overview & Discovery
👉 Understand how a drug idea evolves into a development candidate
Session 1: Drug Development Landscape (2026 Perspective)
- End-to-end drug development lifecycle
- Types of products: small molecules, biologics, gene & cell therapies
- Routes of administration & formulation considerations
- Current industry trends (personalized medicine, AI-driven discovery)
Session 2: Global Pharma Market & Stakeholders
- Global market trends & key therapeutic areas
- Biologics vs small molecule market share
- Roles & responsibilities across R&D, Regulatory, QA, Clinical
- Emerging markets & outsourcing trends
Session 3: Drug Discovery & Early Research
- Target identification & validation
- Impact of genomics & precision medicine
- Lead identification, screening & optimization
- Translational research concepts
Session 4: Introduction to Regulatory Pathways
- Overview of regulatory agencies (FDA, EMA, global)
- IND application fundamentals
- Accelerated pathways (Fast Track, Breakthrough, etc.)
Day 2: Preclinical Development & Regulatory Submissions
👉 Prepare your product for first-in-human studies
Session 1: Preclinical Development
- In vitro & in vivo studies
- ADME (Absorption, Distribution, Metabolism, Excretion)
- Toxicology studies (acute, chronic, genotoxicity)
- Bioavailability & formulation strategies
Session 2: CMC & Formulation Development
- Chemistry, Manufacturing & Controls (CMC) basics
- Polymorphism, salt selection, stereochemistry
- Dosage forms & delivery systems
- Scale-up considerations
Session 3: Regulatory Submissions (CTD/eCTD)
- Common Technical Document (CTD) structure
- eCTD format and digital submissions (2026 expectations)
- US vs EU submission pathways
- Preparing high-quality regulatory dossiers
Session 4: Risk-Based Development
- ICH Q8, Q9, Q10 principles
- Quality by Design (QbD)
- Risk assessment tools (FMEA)
Day 3: Clinical Development & Digital Transformation
👉 Learn how drugs are tested, validated, and optimized in humans
Session 1: Clinical Trial Phases & Design
- Phase I–III clinical trials
- Study design, endpoints & protocols
- Patient recruitment & retention challenges
Session 2: Good Clinical Practice (GCP) & Compliance
- GCP principles & inspection readiness
- Roles of sponsors, CROs, investigators
- Data integrity & audit readiness
Session 3: Digital & Decentralized Clinical Trials (2026 Focus)
- Decentralized trials (DCTs) & hybrid models
- Use of AI, wearables & real-world data (RWD)
- Electronic data capture (EDC) & remote monitoring
- Regulatory expectations for digital trials
Session 4: Safety & Pharmacovigilance in Clinical Trials
- Adverse event reporting
- Signal detection basics
- Risk management during trials
Day 4: Approval, Post-Market & Lifecycle Management
👉 Successfully bring products to market and sustain compliance
Session 1: Regulatory Approval Process
- NDA / BLA submission overview
- FDA/EMA review process
- Advisory committees & approval timelines
Session 2: Manufacturing & Commercial Readiness
- GMP requirements for commercialization
- Process validation & technology transfer
- Supply chain considerations
Session 3: Post-Approval Changes & Lifecycle Management
- ICH Q12 and post-approval flexibility
- Managing variations & changes
- Lifecycle management strategies
Session 4: Pharmacovigilance & Market Success
- Post-marketing surveillance (Phase IV)
- Global pharmacovigilance systems (US & EU)
- Risk management plans (RMPs)
-
Product launch & market access basics
Who will Benefit:
- Medical and clinical investigators
- Investigation & expansion scientists
- Quality Assurance professionals
- Scientific Research professionals
- Auditors
- Strategic planners
- Senior sales managers
- Regulatory Affairs Professionals
- Non-scientific employees of pharmaceutical companies who would like to understand how drugs are developed
- Regulatory affairs professionals
- Project managers
- CMC/pharmaceutical research professionals
- Manufacturing Personnel
- Newly-appointed staff with no previous experience in the pharmaceutical industry
- Financial managers
- Brand team personnel
- Statisticians & data management professionals
-
A pharmaceutical employee who wishes to better their knowledge of drug development
Know Your Faculty
Kelly Thomas, Head Of Quality Assurance (USA)
Highly experienced Quality Assurance / Quality Control / Regulatory Compliance leader with experience in API, biologics / biotech, both aseptic and terminally sterilized manufacturing processes, medical devices, drug / device combination products, and all pharmaceutical dosages (Sterile Injectable, OSD, Controlled Substances, Aerosols).
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.
High degree of quality understanding and ability to apply knowledge of global regulatory requirements particularly with process / equipment validation, new product and technology transfer, lot/process investigations, quality systems, quality control, data trending, lab equipment and validation.
