ICH Q12 -

Product Life Cycle

Now available:
Step 2 Draft document on ICH Q12 has
Management
been published in December 2017!
13-14 November 2018, Berlin, Germany

Speakers

HIGHLIGHTS:
„„ Current Status of the proposed document
DR BERNHARD BÖHM „„ Views and expectations of regulators & inspectors
Boehringer Ingelheim
„„ Key elements of Lifecycle Management:
–– Quality & Supply Risk Management
–– Global Change Management
DR GRAHAM COOK –– Use of Knowledge
Pfizer, ICH Q12 EWG Member „„ “Established Conditions” and “Comparability Protocols”
„„ Application of ICH Q12 for currently marketed products
„„ Industry strategies to use ICH Q12 effectively

DR HILTRUD HORN
HORN Pharmaceutical
Consulting

LUISA PAULO
Hovione, ICH Q12 EWG Member

DR JEAN-LOUIS ROBERT
EMA, ICH Q12 EWG Member
(EU topic leader for ICH Q12)

DR FRANZ SCHÖNFELD
GMP Inspector

This conference is recognised for the ECA GMP Certification Programme „Certified Pharmaceutical Development Manager“.
Please find details at www.gmp-certification.eu
 ICH Q 12 - Product Life Cycle Management
13-14 November 2018, Berlin, Germany

Objectives & Background Programme

The ICH Q12 topic was endorsed by the ICH Steering Com- ff Day 1
mittee in September 2014. Now progress has been made
towards developing the draft ICH Q12 Guideline on Techni- Update on ICH Q 12 – Current Status of the proposed
cal and Regulatory Considerations for Pharmaceutical Prod- document
uct Lifecycle Management: Dr Jean-Louis Robert
The Step 2 a/b draft document has been published for com- •• Current status
ment since December 2017.
The new guideline has been developed to complement the How ICH Q8-Q12 Guidelines work together from
existing ICH Q8 to Q11 guidelines, especially to enable full Development to Product Realization and Continuous
realization of more flexible regulatory approaches to post- Improvements
approval CMC changes. The guideline applies to pharma- Dr Hiltrud Horn
ceutical drug substances (i.e., active pharmaceutical ingredi- •• What is important for Development of APIs and Drug
ents, APIs) and pharmaceutical drug products, including Products in EU and US?
marketed chemical, and biotechnological/biological prod- •• What are key points of discussion for APIs and Excipients?
ucts. The guideline also applies to drug-device combination •• How will ICH Q12 influence our future?
products („Drug-delivery products“) that meet the definition •• What are key aspects that you should know to avoid
of a pharmaceutical or biotechnological/biological product. unnecessary variations?

Therefore, the Q12 draft includes chapter on Established Key elements of Lifecycle Management: Quality and
Conditions (ECs), Post Approval Change Management Pro- Supply Risk Management
tocols (PACMPs), Product Lifecycle Management (PLCM) •• Balance between quality, cost and risk
documents, Pharmaceutical Quality System (PQS) and •• Portfolio aspects
Change Management, categorization of post-approval CMC •• Teams, processes and governance
changes, relationship between regulatory assessment and Dr Bernhard Böhm
inspection, and the application of Q12 for currently market-
ed products. Furthermore, the guideline describes how ECs Key elements of Lifecycle Management: Global Change
are identified as well as what information can be designated management
as supportive information that would not require a regulato- •• Multi-site change management: local vs. global
ry submission, if changed. Guidance is also included for •• Prioritisation, planning and efficiency
managing revisions of the ECs over a product’s lifecycle. •• Teams, processes and governance
•• Change management and regulatory activities
Conference presentations, case studies and open discus- Dr Bernhard Böhm
sions will help participants learn more about the lifecycle
management of pharmaceutical products and provide a fo- Identifying “Established Conditions” for Manufacture
rum for discussing ICH´s new guideline. Participants will and Control
thus have the opportunity to give feedback and ask Luisa Paulo
questions directly to ICH´s Expert Working Group (EWG)
members on how to move forward with the transition Views and expectations of Inspectors
to and implementation of the lifecycle approach. Dr Franz Schönfeld
The meeting will also address topics such as:
•• Identifying “Established Conditions” for Manufacture and
ff Day 2
Control
•• How could Postapproval Change Management Protocols
How could the utility of proposed Q12 tools of Day 1
(“Global Comparability Protocols”) look like? simplify post approval changes?
•• Validation as part of lifecycle activity: What is the impact
Dr Jean-Louis Robert
of ICH Q12 on analytical method and process transfer? •• Analytical methods
•• What are the skills and interfaces a „Global Life Cycle
•• Manufacturing process
Manager“ or „Global Change Manager“ needs? •• Manufacturing site

Target Audience What is the impact of ICH Q12 on analytical method and
process transfer?
The ECA wishes to actively involve QA personnel dealing •• How can you use ICH Q12 for method and process
with global change management, analytical chemists, QC changes?
analysts, R&D scientists, as well as manufacturing scientists •• What is the difference prior and after ICH Q12?
(process developers) and managers, and regulatory affairs •• How should you proceed in your daily practice?
specialists and regulators. •• What should you know about CMC vs. GMP-aspects
(dossier/inspections)?
•• Practical examples
Dr Hiltrud Horn
What are the skills and interfaces a „Global Life Cycle ff DR HILTRUD HORN
Manager“ or „Global Change Manager“ needs? HORN Pharmaceutical Consulting, Germany
•• Scope models: how comprehensively to manage Hiltrud Horn is managing director of HORN PHAR-
products? MACEUTICAL CONSULTING with focus on CMC,
•• Matrix management GMP and Regulatory Affairs (EU and US). She started
•• Leadership skills in pharma industry in 1990 and held several mana-
•• The ideal team – experience and diversity gerial positions within Hoffmann-La Roche in Basel and
Dr Bernhard Böhm Knoll (now Abbott) in Ludwigshafen with global responsibil-
ity within QC / QA / Regulatory Affairs / Project Manage-
How could Post-approval Change Management Proto- ment / Medical Writing. She was consultant for the biotech
cols (“Global Comparability Protocols”) look like? and life science industry at Cap Gemini Ernst & Young prior
Luisa Paulo to starting her own business more than 15 years ago. She is
pharmacist with a Ph.D. and holds a Diploma in Pharmaceu-
Industry strategies to use ICH Q12 effectively tical Medicine (Basel). Furthermore she is specialized phar-
Dr Graham Cook macist for pharmaceutical analytics and for drug informa-
•• How much the industry will benefit from the guideline tion.
•• How it will impact the post approval changes
•• What type of changes will benefit ff LUISA PAULO
ICH Q12 EWG Member, Hovione, Portugal
End of Life Cycle – How to manage? Luisa is Compliance Director at Hovione and Chair
•• Portfolio analysis and pruning: selection criteria of APIC’s Quality Metrics Task Force. Currently she is
•• Divestiture and withdrawal: what to consider member of the ICH Q12 Expert Working Group
•• Efficient clean-up (EWG) representing APIC.
Dr Bernhard Böhm
ff DR JEAN-LOUIS ROBERT
“Issues under Discussion” and Next Steps Co-opted CHMP member, ICH Q12 EU topic lead, UK
Dr Graham Cook Dr Jean-Louis Robert was head of the Service de
•• Concerns and implications Chimie Pharmaceutique, an official medicines con-
trol laboratory, at the LNS, before retiring in March
2015. He is a member of the Committee for Human
Moderator Medicinal Products (CHMP) since 1995 (co-opted member
since 2004) at the European Medicines Agency (EMA) in
Dr Jean-Louis Robert London and was chairman of the CHMP/CVMP Quality
Working Party from 1995 - 2017. Within the International
Conference on Harmonization (ICH), he is or was involved in
different topics mainly Validation of Analytical Procedures,
Speakers Common Technical Document-Quality, revision of the
guidelines on impurities (Q3A and Q3B), Pharmaceutical De-
ff DR BERNHARD BÖHM velopment (Q8 and Q8R1), Pharmaceutical Quality System
Boehringer Ingelheim, Germany (Q10). He was rapporteur for the Implementation Working
Bernhard Böhm is Vice President Global Product Group ICH Q8, Q9, Q10 and in charge of the ICH Quality Top-
Lifecycle Management Operations. After joining the ic Recommendation Working Group. Currently he is EU topic
pharmaceutical industry at Solvay Pharmaceuticals, leader for Life Cycle Management ICH Q12.
he held various positions in production, QA and
Regulatory Compliance at Solvay’s German and French ff DR FRANZ SCHÖNFELD,
manufacturing sites. WithinB oehringer Ingelheim, he head- District Government of Upper Franconia, Germany
ed R&D Project Management units in Germany and the US. Franz Schönfeld is GMP Inspector and Head of the
Expert Working Group for APIs and excipients at the
ff DR GRAHAM COOK German Central Authority of the Federal States for
ICH Q12 EWG Member, Pfizer, UK Health Protection (EFG 07/ ZLG).
Graham is part of Pfizer’s Global Quality Strategy
group working on regulatory intelligence and
external engagement, and leading the Pfizer team
implementing the GMP aspects of the EU Falsified Social Event
Medicines Directive. He was appointed to the British Phar-
macopoeia Commission in 2010 and elected Chairman of In the evening of the first conference day, you
the ASTM International E55 Technical Committee develop- are cordially invited to a social event. This is an
ing pharmaceutical manufacturing standards in 2012. He is a excellent opportunity to share your experienc-
pharmacist with a Ph.D. in pharmaceutics. Currently he is es with colleagues from other companies in a
one of the members of the ICH Q12 Expert Working Group relaxed atmosphere.
(EWG) representing EFPIA.
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