Pharma and Biotech Quality Summit

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Conference Overview change for What is Pharma and Biotech Quality Summit about?

It’s a 2-day summit that make you stop fear about what audits might uncover.  
 
One gap in data integrity, contamination control, or digital validation can escalate quick and change observations to costly delays and reputational damage. Be sure about your decisions, and alignment at leadership level without last-minute firefighting: 

  • Stay calm before audits – know what inspectors will challenge and how to evidence control in real operations. 
  • Reduce the risk of costly findings – strengthen the decisions that protect license, supply continuity, and patient trust. 
  • Get access to decision-makers – align with CQOs, Heads of QA/QC, QPs and Operations leaders shaping what “good” looks like now. 
  • Revolutionize quality assurance – Navigate the complexities of global regulations, ATMPs, and personalized medicine while learning cutting-edge strategies for contamination control, data integrity, and sustainable quality management. 
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One Quality Gap Can Cost More Than a Year of Prevention

Regulatory findings are not administrative inconveniences. They trigger cascading financial impact across operations, legal exposure, supply continuity, and brand credibility.

Cost Category
Typical Range (Indicative)
Financial Impact
Regulatory fines / enforcement actions

Investigation & remediation program

Production downtime / lost batches

Legal & external audit support

Supply disruption & backlog recovery

Reputational impact & partner scrutiny
€200,000 – €2,000,000+

€500,000 – €5,000,000+

€1,000,000 – €10,000,000+

€100,000 – €1,000,000

€500,000 – €10,000,000+

Difficult to quantify
Immediate financial penalty and follow-up inspections

Root cause analysis, CAPA redesign, re-validation, external consultants

Idle capacity, rework, scrapped product, delayed release

Legal advisory, third-party audits, regulatory negotiations

Expedited logistics, contract penalties, customer impact

Increased oversight, delayed approvals, lost partnerships

Event speakers

Barbara Glantschnig
SVP Global Quality, Plasma Derived Therapies
Takeda, Austria
Dr. Rob Reid
Deputy Director, Innovative Devices
MHRA, UK
Soeren Dam
Associate Director Quality Intelligence
Novo Nordisk, Denmark
Beatriz Sanchez | Speaker | Fleming
Beatriz Sanchez
Global Head GMDP/GQP Audits
Kyowa Kirin Inc, United States
Michalina Szatała
One Day Batch Release Lead | Global Quality Strategy & Business Operations
Takeda, Switzerland
Ewa Rybak
Head of Quality Compliance and Quality Systems/Qualified Person
JJP Biologics, Poland
Marta Rodriguez Velez
Quality Assurance
LETI Pharma, Spain
Bruno Morgado
Senior Director, Head of QA & QP
Fresenius Kabi, Portugal
Maxim Bunimovich
CEO, Co-founder
The QARP, Spain
Roman Rolka
Quality Consultant
Austria
Fabio Geremia
Quality & Compliance Director
Italy
Vincenzo Mazza
Regulatory Quality Assurance Audit Senior Manager
Pfizer, Italy
Sandra Lopes Guerreiro
Head of Global Quality, Health, Safety and Environment
ESTEVE, Spain
Christoph Meyer
Global Head of Quality Lonza Specialized Modalities
Lonza, Switzerland
Pascal Heber
Senior Director Quality
Lonza, Germany
Natalia Vtyurina, PhD
Chair of ISPE NL Quality CoP
ISPE, Netherlands
Forum

Highlights

Conference

Brochure

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Why Attend Pharma & Biotech Quality Summit?

Testimonials

Sponsors

Gold Sponsor

ADAMAS Consulting | Gold Sponsor | Fleming

Partners

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PharmaShots | Media Partner | Fleming

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Pharma Now | Media Partner | Fleming

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Pharma Tech Outlook | Media Partner | Fleming

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Registration

Tickets

1 Delegate 
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3 Delegates
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Venue

Leonardo Hotel Munich Arabellapark

Effnerstraße 99,
81925 Munich, Germany
Phone: +49 89 927 980

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Contact us

Natalie Pearson
Marketing Manager for Pharma

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