GMP Conference - Wednesday, 24 October 2018

 Maria Filancia


Maria Filancia, Committees and Inspections Department, EMA, United Kingdom

  • International collaboration on GMP inspections
  • EU-US MRA scope and applicability
  • EU-US MRA timelines and milestones
  • EU-US MRA implementation
  • Next steps


 Rainer Gnibl

Current findings from EU-GMP inspections at EU- & Asian API-manufacturers

Rainer Gnibl, EU GMP Inspector, Bavarian Government, Germany

  • Which areas supposed to get critical
  • Major & critical deficiencies found  
  • Difference between asian- & EU-companies?


 Arjen te Nijenhuis

Brexit: consequences for the API industry

Arjen te Nijenhuis, Janssen Pharmaceutica, Belgium


Amirthini Rajkumar

Current regulatory landscape in Canada

Amirthini Rajkumar, Health Products and Food Branch, Health Canada

  • Use of CEPs as supporting information in drug submission
  • Use of foreign reviews in Canada
  • Recently published quality guidance documents
  • Current developments


Danny de Scheemaecker

Data Integrity in API manufacturing

Danny de Scheemaecker, Janssen Pharmaceutica, Belgium

  • A practical risk-based guidance on the implementation of data integrity measures compliant with current regulatory guidance's
  • Explanation of an overall DI assessment approach, starting from business processes and data mapping until final risk management.
  • How to do in practice (some examples)


 Robert A. Dollinger

FDA latest initiatives in 2018

Robert A. Dollinger, DASTECH International, USA



Parallel Sessions - Thursday, 25 October 2018

>> Please click to enlarge. <<


Joint GMP and Regulatory Affairs Day - Thursday, 25 October 2018

 David Cockburn

What can authorities do about drug shortages?

David Cockburn, formerly European Medicines Agency (EMA)

  • Who is responsible for medicines supply?
  • What causes medicines shortages?
  • Which causes can be influenced by regulatory authorities?
  • Examples of practical measures
  • Is there a need for industry guidance?
 Oksana Golycheva

API registrations in Eastern Europe

Oksana Golycheva, Janssen Pharmaceutica, USA

  • What does current Russian/Eurasian union API legislation look like?
  • How is the Russian Health Authority organised?
  • API legislation process for initial submissions and post approval changes
  • What is role and impact of inspections on the registration process?


 Gabriel Ramos Ferronatto

Update on ANVISA activities

Gabriel Ramos Ferronatto, ANVISA, Brazil


 Hélène Bruguera

Update on EDQM activities

Hélène Bruguera, EDQM France

  • Preparing the 10th edition of Ph. Eur – hot topics
  • Update on the CEP procedure
  • Changes to revisions of CEPs
  • Update on EDQM inspections


Regulatory Affairs Conference - Friday, 26 October 2018


After several Regulatory topics will have been presented during the second conference day, the RA conference will highlight key aspects of the EU ASMF assessment worksharing, industry’s perspective on ICH Q12, the latest Chinese API regulations and international harmonization programs.


 Martijn Klop

EU ASMFs: worksharing and eCTD

Martijn Klop, Synthon, The Netherlands

  • The EU ASMF assessment worksharing
  • eCTD submissions in the EU


 Markus Goese

ICH Q12 – Industry point of view

Markus Goese, F. Hoffmann-La Roche, Switzerland

  • Established conditions
    - What does it mean?
    - How to define?
    - Expected impact on variations
  • PACMP – Post Approval Change Management Protocols
    - Purpose
    - Why and how a PACMP can help?
  • PLCM – Product Life Cycle Management: Purpose
  • Why and how it should be included in the CTD?



The changes in the regulatory procedures in China: expectations from the Health authorities with respect to API information

David Zhou, China Chamber of Commerce for Import and Export of Medicines and Health Products(CCCMHPIE), China


 Speaker Marieke van Dalen

Global harmonization: Utopia?

Marieke van Dalen, Global CMC RA/CRS, Aspen Oss B.V., The Netherlands

  • International harmonization programs
  • Current status  
  • Way forward