Certificate Course on
Biopharmaceutics in Drug Development
Conducted by
SOPHAS
Duration
6 months (July 2026 to December 2026)
Teaching Methodology
Flipped Classroom approach
Target Audience
Designed for early-career pharmaceutical professionals, researchers, formulation scientists, regulatory affairs professionals, clinical trial managers, educators, academic researchers, graduate and postgraduate students, and professionals transitioning into biopharmaceutics and drug development who seek practical expertise in biopharmaceutics, mechanistic modeling, and modern drug development approaches.
Objectives
- Develop a strong foundation in bioequivalence (BE), biopharmaceutics, and regulatory principles relevant to modern drug development.
- Apply Biopharmaceutics Classification System (BCS/MCS) concepts and statistical methods to evaluate formulation performance and robustness.
- Learn to establish In Vitro–In Vivo Correlations (IVIVC) for predicting clinical performance and optimizing dosage forms.
- Explore advanced modeling approaches, including Physiologically-Based Pharmacokinetic (PBPK) and mechanistic absorption modeling, to support formulation and development decisions.
- Understand current FDA and global regulatory guidelines for biopharmaceutics, dissolution specifications, and biowaivers.
- Strengthen practical decision-making skills through industry-relevant case studies, expert interactions, and data-driven approaches to formulation development.
Course Structure
Structured Virtual Learning
Duration: 6 months (July 2026 to Nov 2026)
Format: Online, self-paced with guided materials
This phase focuses on building a strong foundational understanding through structured self-paced learning.
Participants will gain:
- Access to recorded lectures, course materials, and licensed software tools for independent study and practice
- Curated readings and learning resources aligned with course outcomes
- Assignments and exercises designed to reinforce core concepts and prepare participants for advanced, hands-on work in later phases
By the end of this phase, learners will be well-equipped with the theoretical background and tools needed for the application-oriented stages of the program.
Topics to be Covered:
Covers the foundational concepts of biopharmaceutics and pharmacokinetics, including physicochemical properties, anatomy and physiology, and formulation development. It also introduces in vitro method development and regulatory expectations for dissolution and biowaivers.
Focuses on applying fundamentals to develop bio-indicative dissolution methods for solid and complex dosage forms. It also addresses biowaivers, SUPAC changes, and regulatory aspects of dissolution specifications and similarity. Plan to cover in depth about dissolution evaluation from biopharmaceutics and biopredictivity perspectives.
Provides core understanding of pharmacokinetics, including ADME processes, modeling approaches, and enzyme/transporter effects. It also introduces bioequivalence concepts and global regulatory requirements. Along with USFDA, EMA, harmonized ICH guidance and other specific agency requirements may also be covered.
Emphasizes advanced applications such as BE data analysis, IVIVC development, and PBPK modeling. It also covers virtual bioequivalence, food effects, and critical bioavailability considerations. Few aspects on 505b(2) may also be covered.
Involves practical learning through case study discussions integrating earlier modules. Concludes with capstone project presentations to apply and demonstrate overall understanding.
Instructors
Dr Yasvanth Ashokraj
Director, Biopharmaceutics & Pharmacokinetics, Cipla Ltd
Dr Sivacharan Kollipara
Head, Biopharmaceutics, Global Clinical Management, Dr. Reddy’s Laboratories Ltd
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Category
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INR (₹) Fee
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|---|---|
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Students/Trainees
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₹20,000
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Academics
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₹25,000
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Industry
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₹40,000
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Account Name: EVINAHTA CONSULTANCY PRIVATE LIMITED
Account Number: 007205002908
Account Type: Current
IFSC Code: ICIC0000072
Branch: Manipal, Karnataka
*In the Add Note section, please add Full name & Institution/Industry Name & City
OR
Pay via our Razorpay link: https://rzp.io/rzp/biopharm
NOTE: Please fill the registration form once the payment has been done.
Registration Form
For group registrations & fee related queries, reach out to us at connect@sophas.net and unlock a smoother, faster onboarding experience.
Upon completing the payment, please ensure you upload the payment proof and enter the Transaction ID in the registration form, along with the other required information.