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The U.S. Food and Drug Administration (USFDA) India Office and the Drug Information Association’s (DIA) India Office will host a 2 -day workshop on regulatory policies, guidance and support for the adoption of advanced manufacturing technologies featuring USFDA, Pharmaceuticals and Medical Devices Agency (PMDA), Therapeutic Goods Administration (TGA), Central Drugs Standard Control Organization (CDSCO) and Industry representatives.

This comprehensive program offers a unique opportunity to hear from multiple regulators on current perspectives on advanced manufacturing technologies. The Regulators will speak on various initiatives taken by the respective agencies and the ways in which they are facilitating the adoption of advanced manufacturing technologies. Pharmaceutical industry representatives will discuss advanced manufacturing technologies, the advanced manufacturing landscape in India, and share views on current opportunities and challenges. Each day will conclude with a panel discussion with the relevant speakers.

Featured topics

  • Overview of the Advanced Manufacturing Technologies Program
  • Regulatory Resources for Advanced Manufacturing Technologies
  • Process Analytical Technologies (PAT)
  • ICH Q13
  • Indian landscape for Advanced Manufacturing Technologies
  • Indian Industry Experience

Learning objectives

The objective of this workshop is to share agencies’ thinking on this topic, industry’s adoption of this topic and facilitate an active dialogue to encourage a better understanding of regulatory expectations. The workshop will focus on the need for accelerating the adoption of advanced manufacturing technologies, regulatory support and various initiatives from the regulatory agencies. Workshop participants will have opportunities for questions and answers with industry experts and regulatory agency representatives.

Program Committee

  • Sarah E McMullen
    Sarah E McMullen Country Director, FDA India Office
    Food and Drug Administration, India
  • Natalie  Mickelsen
    Natalie Mickelsen
    Food and Drug Administration, India
  • Kristan  Callahan
    Kristan Callahan International Relations Specialist
    U.S. Food and Drug Administration, India
  • Gregory  Smith
    Gregory Smith Deputy Director, FDA India Office
    Food and Drug Administration, India
  • Dhruv   Shah
    Dhruv Shah Senior Technical Advisor
    Food and Drug Administration, India
  • Thomas  O’Connor
    Thomas O’Connor Deputy Director Office of Testing and Research Office of Pharmaceutical Quality
    USFDA, United States
  • Sharmista  Chatterjee, PhD
    Sharmista Chatterjee, PhD Division Director in Division of Pharmaceutical Manufacturing II,
    Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ/CDER, FDA, United States
  • Manuel  Osorio, PhD
    Manuel Osorio, PhD Senior Scientist for Emerging Technologies, OD, CBER
    FDA, United States
  • Yoshihiro  Matsuda, PhD
    Yoshihiro Matsuda, PhD Senior Scientist (for Quality), Pharmacist
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Sau L Lee, PhD
    Sau L Lee, PhD Deputy Director of Science, OPQ, CDER
    FDA, United States
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