Skip to Content
Merck
CN
HomeWebinarsNavigating Risk and Change - Day 3

Navigating Risk and Change - Day 3

Webinar

Global Regulatory Updates: Strategic Insights into Annex 1, MAT, RMM, and ABP Compliance

Session 1: EU GMP Annex 1 Compliant Air Monitoring: Choosing the Right Equipment and Key Features for Effective Microbial Sampling

In this session, you will learn:

  • How to choose suitable types of equipment
  • What are important features of air sampling equipment

Session 2: Monocyte Activation Test (MAT) in India: Bridging Regulatory Frameworks and Industrial Adoption

In this session, you will learn:

  • MAT offers a broad-spectrum pyrogen detection in quality control of biopharmaceuticals and medical devices.
  • Bridging the “validation gap” is critical for industry confidence.
  • Technology awareness and hands-on training opportunities will influence adoption decisions.
  • Product-specific implementation remains a key challenge.

Session 3: Update on the regulatory landscape and technical application of rapid microbiological methods

In this session, you will learn:

  • Why rapid microbiological methods (RMM) and main RMM types
  • Evolving regulatory positions of Ph.Eur., USP and ChP on rapid microbiological methods
  • Milliflex® Rapid System 2.0 validation and application

Session 4: Animal By-Product Regulations, Implications to Global Trade

In this session, you will learn:

  • Difference between customer and customs driven requirements.
  • Introduction into import/export conditions.
  • Practice insights in dealing with import/export conditions.
     

Speakers

Kenny Tay

Kenny Tay

Merck

Head of Commercial Applications, APAC

Kenny holds a BSc in Molecular Biology and Biomedical Science. With over 8 years experience specializing in QC microbial testing and environmental monitoring at MSD and Lonza, he joined in 2014 as Biomonitoring Business Manager for SEA. He has since established himself as a technical expert for SEA and APAC, driving digital innovation. In 2025, he became Head of Commercial Applications, APAC, overseeing Biomonitoring marketing and lab services across the region.

Dr. Rohit Bisht

Dr. Rohit Bisht

PETA India

Senior Scientist- Regulatory Testing (Pharm & Med Devices), PETA India

Dr. Bisht is a pharmaceutical scientist with a strong foundation in drug discovery and development. He holds a Master’s degree in Pharmaceutical Sciences, a Ph.D. from the University of Auckland, and a postdoctoral fellowship at BITS Pilani. His research expertise spans ocular therapeutics and biologics (mAbs and peptides), as well as in vitro safety testing models. He specializes in regulatory affairs and method validation within the context of New Approach Methodologies (NAMs) and contributes to science policy and research policy initiatives.

Sha Zhu, Ph.D

Sha Zhu, Ph.D

Merck

Senior Regulatory Marketing Expert, BioMonitoring

Dr. Sha Zhu, Ph.D. in Applied Microbiology from Justus Liebig University Giessen, Germany, specializes in the development, regulation, and standardization of microbiology across pharma, food, beverage, cosmetics, and water. She previously worked as a microbiological research scientist at a global reference lab for the food industry and a leading third-party lab. She is an active member of ISO, DIN, and GB microbiology committees for food, water, and dairy, collaborates on the Chinese Pharmacopoeia project, and has spoken at Germany’s Aseptikon PharmaCongress and the European Microbiology Jubilee Conference PharmaCongress 2026.

Dr. Tobias Hertzig

Dr. Tobias Hertzig

Merck

Regulatory Affairs Expert

Dr. Tobias Hertzig holds a Master’s degree in Microbiology and a Doctorate in Virology. He brings almost two decades of experience in trade compliance and regulatory affairs for products with veterinary requirements. His expertise centers on import and export regulations for Life Science products containing animal-origin components at an international level. Tobias has served as current and past Chair of Animal By-Products task forces across multiple trade associations, and he engages in advocacy with veterinary authorities in approximately 20 countries. He is a qualified lead auditor with a specialized focus on animal-origin traceability, ensuring rigorous compliance across global supply.

Parag Vachhani

Parag Vachhani

Merck

Senior Expert in Regional Commercial Applications, APAC

Parag has over 10 years of experience in various high-impact teams within the life science industry. His expertise focuses on strategic product marketing and the development of regional commercial applications. He is responsible for managing product lifecycles and establishing marketing strategies specifically for the APAC market to support business growth. 

Webinar Information

Pharma and biopharma manufacturing

  • Classical pharma manufacturing
  • Duration:4h

  • Language:English

  • Session 1:presented July 9, 2026

    Watch now