Fundamentals in Regulatory Management

Sector Information

Chemical:

The chemical industry, responsible for various products, enforces global chemical regulations to protect human health, preserve the environment, and ensure safe trade. The EU's REACH regulation is the gold standard, while the US's EPA enforces the TSCA. Asia-Pacific powers like China and South Korea have developed their own REACH-like systems. Understanding these regulations is not just a legal necessity but also a competitive advantage.

Cosmetics:

Cosmetics is a tightly regulated industry that requires products to comply with strict rules to protect consumers and maintain trust. European countries have stricter regulations, while the US is enhancing FDA oversight with the Modernization of Cosmetics Regulation Act. China has streamlined approvals and easing animal testing requirements. Other regions are moving towards transparency, ingredient safety, and stricter labeling requirements. Compliance is becoming a competitive advantage as consumers demand cleaner, greener, and safer beauty products.

Agrochemical

Agrochemicals are crucial for modern agriculture, but their environmental impact and potential health risks make them highly regulated globally. Compliance is complex due to different regulations across countries, including the EU and the US. Emerging trends include harmonization efforts, sustainability pushes, and digital submissions and data transparency. Understanding these regulations is essential for safe innovation, successful market access, and sustainable agriculture worldwide.

FCM

Food Contact Materials (FCMs) are crucial for food safety worldwide, ensuring non-toxic substances don't transfer harmful substances. Regulations focus on material safety, migration limits, and traceability and compliance. Key regions include the EU, US, China, Japan, Brazil, and MERCOSUR. The FDA oversees FCMs through the Food Contact Notification process, while China sets rigorous testing protocols and material-specific guidelines. Emerging trends include sustainability requirements, increased scrutiny of chemicals, and global harmonization efforts. Understanding FCM regulations is essential for market access, consumer trust, and staying ahead of global trends.

Pharmaceutical

The pharmaceutical industry is highly regulated globally, ensuring patient safety and public health. Key pillars include rigorous clinical trials, Good Manufacturing Practice (GMP), global harmonization efforts, and pharmacovigilance. The regulatory landscape is evolving rapidly due to digital health tools, personalized medicine, biologics, and faster market access. Professionals must understand this complex web of regulations to ensure safe, effective, and high-quality medicines before reaching patients.

Schedule

• The sector-specific course will start in November 2025, and the course duration is 5-6 months.

  Lectures for the Modules are held every two weeks during this period. All forms of assignments are meant to be completed in the time during the Modules. The final project will be worked on independently after this time.

Mode of Delivery

The course will be delivered online through a Learning Management System (LMS) platform, allowing participants to access materials and lectures at their convenience. All sessions are pre-recorded for self-paced learning, enabling individuals to balance their professional commitments with their educational pursuits. On-demand live Q&A sessions will be conducted to address the queries and facilitate interaction with experts.

Structure

Content: 1-3 Presentations (depending upon the Part)

Evaluation: 1 quiz and 1 assignment per Part

Q&A sessions: 1 Live Q&A and 1 on-demand Q&A (per part)

Assessment

Assessment will be based on quizzes (that contain multiple-choice questions), Assignments, and capstone projects, designed to evaluate participants' comprehension of course material and their ability to apply concepts in practical scenarios.