ISPE Regulatory Digest Q3 2023

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.

Regulators on Trust, Collaboration, Reliance, Harmonization, Innovation, Agility, QMM, and more

EMA Executive Director on the Value of Adaptation, Trust, and Collaboration

Emer Cooke, Executive Director of the European Medicines Agency (EMA)

Emer Cooke talked about the EMA’s role in protecting public health in times of crisis, focusing on three drivers that helped the Agency overcome the COVID-19 pandemics challenges and using those lessons to prepare for, and even prevent, future crises. Read More

FDA Office of Quality Surveillance on Quality Management Maturity

Jennifer Maguire presenting keynote (May 9)

Jennifer Maguire detailed the FDA’s initiative to develop a QMM rating program intended to incentivize manufactures to invest in culture and to drive continual improvement and innovation. A high QMM rating is intended to recognize performance beyond basic good manufacturing practices. Read More

EMA on International Cooperation, Harmonization, and Reliance in GMP

Peter Twomey, Head of Inspections for the European Medicines Agency (EMA)

Peter Twomey described how EMA continually looks at regulations to ensure they are fit-for-purpose as well as seeks ways to increase international regulatory harmonization and maintain adequate inspection capacity. Read More

Industry-regulatory discussion panels

Regulators from Europe and the US addressed the technology and policy initiatives transforming the pharmaceutical manufacturing landscape:

  • Innovation, regulatory agility and speed, workforce skills for both industry and regulators, and the role multinational companies can play in support of global harmonization efforts for inspections. Read More
  • Principles for technology and regulatory oversight in digital transformation and Pharma 4.0™. Read More

ICH Q9(R1): The Next Frontier

Advancing the effectiveness of quality risk management and risk-based decision making, enabling innovation in the pharmaceutical workplace of the future, and supporting digital transformation are three knowledge application areas key to the development, manufacture, and supply of pharmaceutical products. Read More

Barriers to Innovation: ISPE Survey Results

ISPE has been conducting a survey to gather data on how global regulatory divergence, product development and business factors contribute to challenges or barriers in developing and implementing innovative technologies. The survey findings will be presented at the session, Global Regulator Harmonization Initiatives to Advance Approvals of Innovative Products, Technologies and Modalities on 16 October at the 2023 ISPE Annual Meeting & Expo.

It’s not too late to add your input. Take the Survey

ISPE Comments on Draft Guidelines

ISPE provides the opportunity for members to propose comments on select draft regulatory guidelines or guidances. Commenting opportunities are published in the Regulatory and Quality Networking Community.

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