iSpeak Blog

Quality and Regulatory Challenges, Learnings, and Future Opportunities

Connie Langer
Ciby Abraham, PhD
Quality and Regulatory Challenges, Learnings, and Future Opportunities

While everyone is facing new speed to market expectations, we should consider and discuss why global regulatory barriers are increasing, why science- and risk-based strategies often mean more data are required, and why regulatory approval for new technologies and new medicines seems more challenging than ever before. We can no longer afford to delay innovation, product and process improvements, and new technology because of diverging global requirements. This year’s Regulatory and Quality sessions at the 2022 ISPE Annual Meeting & Expo will cover regulatory and quality challenges, learnings, and opportunities, such as building a quality organizations, quality management maturity, development and implementation of new and emerging ICH guidelines, and regulatory considerations to boost innovation and supply chain resilience.

The pace of innovation in the pharmaceutical field is accelerating, and the development of a global, flexible and harmonized regulatory framework will be a key enabler to bring medicines to patients faster. Since its inception, ICH has been concerned with establishing global convergence and alignment on technical criteria with the intent to harmonize regulatory expectations. Industry representatives will discuss current barriers to harmonization and to implementation of innovative technologies. In addition, full sessions on the new paradigm for analytical methods introduced in the Step 2 ICH Q2(R2)/Q14 guidelines and progress and future opportunities with ICH Q12 implementation will be included. The analytical session will include and provide audience opportunity to ask questions of current ICH Q2(R2)/Q14 Expert Working Group regulator and industry representatives. Sessions will highlight examples of how to overcome technical and regulatory challenges, streamline the post-approval change management process by promoting the adoption of flexible science- and risk-based approaches and enable supply chain resilience.

2021 ISPE Annual Meeting & Expo

Advanced therapy medicinal products (ATMPs) face new and complex technical, regulatory and quality hurdles; perhaps the greatest of which is scale. In particular, manufacturers face unique challenges when developing commercial scale processes for autologous cell therapy products. Invited speakers from both industry and regulatory agencies will together to discuss shared challenges and highlight learning opportunities for both as this field evolves.

In addition, representatives from industry with present and discuss with the audience how to build a pharmaceutical quality organization that meets ICH Q10 expectations to “assure the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded.” Senior leaders from Organon, Moderna and Barr Laboratories will consider how to foster a sustainable quality culture that meets necessary compliance requirements internationally. Furthermore, industry and FDA speakers will consider FDA's latest thinking on a quality management system maturity for manufacturing facilities.

On the last day of the 2022 ISPE Annual Meeting & Expo, Michael Kopcha from FDA will introduce the audience to his agency’s initiatives that are in place to ensure the quality of the pharmaceutical products and keep the patients safe. His keynote is followed by the Global Regulatory Town Hall that engages various regulatory agencies to discuss and share their insights on how to overcome the inconsistencies in regulatory assessments around the world. We expect this to be an exciting and informative session that allows a meaningful dialogue between the panelists. Recognizing and understanding the degree of divergence and impact it has on the industry is an important step toward improved global harmonization of control strategies.

We hope you can join us at the 2022 ISPE Annual Meeting & Expo to continue the conversation on harmonized approaches to innovative science- and risk-based strategies to ensure that patients have access to the high-quality medicines they need in a timely and efficient manner.