25th APIC/CEFIC Global GMP & Regulatory API Conference

Wednesday | 26 October

The first day of the Conference provides, besides the first set of Parallel Sessions with various GMP and RA topics, updates about EDQM’s and EMA’s activities.

Update from EMA
Brendan Cuddy, EMA

  • API related topics
  • GMP Inspections/Inspection Database
  • Mutual Recognition Agreements (MRAs)

Sustainability initiatives: Impact on API Industry
Dirkjan van Zoelen, Aspen Oss B.V.

  • A sustainable European API production: the various initiatives
  • How to change to more sustainable production methods
  • What are the challenges for changing?

Keep up-to-date with EDQM Work
Hélène Bruguera, EDQM France

  • Celebrating the 11th edition of Ph. Eur
  • How to facilitate the approval of CEP applications
  • The CEP of the Future is for now
  • Why more than ever international cooperation is needed

Thursday | 27 October

The API world is changing rapidly. On the second day, the focus will be on FDA’s initiatives and activities regarding ICH Q13 and ICH M4 (R2) and their approach to facility assessments/inspections and on the second set of Parallel Sessions about e.g. Regulatory Hurdles, Nitrosamine Impurities and auditing Regulatory Starting Materials (RSM) Manufacturers.

ICH Q2/Q14 – Analytical Procedures – Development and Validation
Mario Hellings, Janssen Pharmaceutica

  • The challenges of including more methods in ICH Q2
  • Scientific approaches to analytical procedure development
  • Relation between Q2/Q14 and other ICH guidelines

Cloud-based Regulatory Assessment: ICH M4Q(R2) and FDA KASA Initiative
Lawrence Yu , US FDA

  • Future Regulatory Assessment and Submission in the environment of Cloud Computing
  • ICH’s attempt in modernizing quality information submission and developing ICH M4Q(R2)
  • FDA’s digitalization effort including Knowledge-aided Assessment and Structured Applications (KASA) initiative

FDA – Update on current initiatives

FDA Approaches to Facility Pre-Approval/Pre-License Inspections during the COVID-19 Pandemic and Beyond
Stelios Tsinontides, US FDA

  • Landscape of manufacturing & supply chains during the Covid-19 Pandemic
  • FDA/CDER’s Response
  • Approach to Facility Assessments/Inspections
  • 704(a)(4) Record Requests
  • Remote Interactive Evaluations (RIEs)
  • Concluding Remarks

Q13 and Continuous Manufacturing Advancement
Rapti Madurawe, US FDA

  • Q13 status update and implementation plan
  • Thoughts on current and future landscape of continuous manufacturing