GMP Conference - Wednesday, 25 October 2017

 Speaker Betsy Frtischel

Quality Metrics - Industry experiences so far

Betsy Fritschel, Johnson & Johnson, USA

  • ISPE feed-back on the Quality metrics initiative implementation
  • Quality metrics reporting – benefits for the industry and patients
  • Constrains, difficulties, challenges to the industry


 Speaker Anabela Marcal

FDA/ EMA Mutual Recognition Agreement: current Status

Anabela Marcal, Head of Committees and Inspections Department EMA, United Kingdom

  • Background of the initiative
  • Hurdles (to) overcome
  • Advantages for Industry


 Speaker Francois Vandeweyer

Regulatory Starting materials: a GMP perspective

Francois Vandeweyer, Janssen Pharmaceutica, Belgium

  • Introduction / Recent Trends
  • Regulatory Guidances and papers
  • Issues for Starting material selection
  • HA expectations
  • GMPs for Starting materials(manufacturing/analytical)
  • Auditing of Starting materials
  • Q&A


 Daniella van Gauwbergen

GDP for APIs: the revised APIC How to do guide

Daniella van Gauwbergen, Janssen Pharmaceutica, Belgium

  • Legal framework of GDP for API and customers’ expectations
  • How to comply with GDP requirements - API industry recommendations (focus on the How To Do Document)
  • How API manufacturer may address GDP compliance for product shipped under non-controlled conditions (Focus on position paper and product supply chain routes qualification strategy)


 Raymnd Boye

Elements of a Successful Control Strategy for Continuous API Production

Raymond Boyse, Eli Lilly, Ireland (confirmed)

  • First commercial continuous manufacturing facility in the EU for small molecule APIs
  • Technical, engineering, environmental and health and safety considerations
  • Regulatory issues and challenges
  • Future Trends


 Speaker Hugo Bonar

Counterfeiting APIs: welcome to the real world!

Hugo Bonar, HPRA, Ireland

  • The development of workable enforcement powers to face the counterfeit/falsified challenges
  • Current trends facing public health from counterfeiting/falsification
  • Challenges from criminal elements – organised or white collar crime
  • What are regulators/law enforcement doing to meet the challenges
  • How can regulatory and industry better cooperate to prevent, detect and challenge counterfeiters


 Open Q and A Session

Open Q&A Session

Take the opportunity to ask and discuss your topics of interest.


Parallel Sessions - Thursday, 26 October 2017

>> Please click to enlarge. <<


Joint GMP and Regulatory Affairs Day - Thursday, 26 October 2017

 Speaker Hélène Bruguera

Update on EDQM activities

Hélène Bruguera, EDQM France

  • The work programme of the Ph. Eur and how to take part in it
  • Recent developments for Ph. Eur texts
  • The CEP procedure: how to build a good CEP application according to most recent requirements
  • The EDQM inspection programme for APIs manufacturers, where are we today?
 Speaker Keith McDonald

 ICH Q11 Q&A, a health authority perspective

Keith McDonald MHRA, United Kingdom

  • Development and manufacture of drug substance – both synthetic and biological origin – according to ICH Q11
  • Selection and justification of starting materials
  • Further clarification and guidance by the ICH Q11 Q&A document
  • Selection of the starting material for a synthetic manufacturing process and its impact on industry and Regulators
  • The objective of the ICH Q11 Q&A
  • Status update on the Q&A document.


 Speaker Jean-Louis Robert

 ICH Q12: Benefit and Challenges from a Regulatory Point of View

Jean-Louis Robert, Co-opted CHMP member, ICH Q12 EU topic lead, United Kingdom


 Speaker Yusuke Okada

Current Status of Generic Drug Review in Japan

Yusuke Okada, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

  • Japanese approach for CMC description method
  • Handling of starting materials based on Q11
  • Change Control and marking description reflecting
  • Expected outcome of Q12
  • Generic CTD compilation


 Open Q and A Session

 Open Q&A Session

Take the opportunity to ask and discuss your topics of interest.


Regulatory Affairs Conference - Friday, 27 October 2017


After several Regulatory topics will have been presented during the second conference day, the RA conference will highlight key aspects of ICH Q3D global implementation and the generic industry’s view as well as the QWP’s perspective. Presentations about the Generic industry’s experience with API variations and case studies of post approval changes will round off the Regulatory Affairs Conference Programme.


 Speaker Mechthild Sander

ICH Q3D global implementation: the generic industry’s view

Mechthild Sander, Alfred E. Tiefenbacher, Germany

  • How is industry progressing with the implementation of the ICFH Q3d guideline?
  • What are the main hurdles to overcome?
  • How can the flow of information between API manufacturers, Finished product manufacturers and Marketing authorisation holders be optimised?


 Speaker Sven-Erik Hillver

ICH Q3D – QWP’s point of view

Sven-Erik Hillver, Medical Products Agency, Sweden

  • How does the risk assessment work in practice?
  • What is the information to be provided by API Industry to their customers
  • What will be covered in the next Q3D and what is the Status?


 Photo Koen Nauwelaerts

Generic industry’s experience with API variations

Koen Nauwelaerts, Medicines for Europe, Belgium

  • API variations as a significant part of the total amount of variations
  • What can regulators and industry do to decrease the regulatory burden?
  • How can predictability of API variations be created?


 Speaker Marieke van Dalen

Post approval changes: a case study

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

  • Challenges with a global product
  • Timelines
  • Implementation of the Change


 Final Discussion  

Final Discussion, Closing Remarks