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2nd Annual
Clinical Quality & Compliance
14. June - 15. June 2017, NH Prague City Hotel, Prague

ICH GCP E 6 addendum

Risk-based monitoring & risk-based auditing

AIFA keynote by

Angela del Vecchio

Head of Clinical Trial Office, AIFA, Italy

Low-cost vs high-quality debate

WHY TO ATTEND

Regulatory expectations on IT systems

Low cost vs high quality debate

Robust & effective vendor quality oversight

Patient safety reporting

TAKEAWAYS & SPECIAL FEATURES

  • E-systems and medical apps for greater clinical quality

  • Improving clinical data integrity

  • Best practices in risk-based monitoring

  • Reducing human errors in clinical trials

  • Keys for a successful vendor quality oversight

  • Workshops

  • Problem-solving roundtables

  • GCP inspectors debate

  • Sponsors, investigators, CROs and regulators under one roof

Meet the speakers

Gunnar Danielsson photo
Sweden flag Sweden

Gunnar Danielsson

Former GCP Inspector at Swedish Medical Products Agency

Gunnar Danielsson has more than 25 years of experience from the field of clinical research within the pharmaceutical industry. He has held various positions covering monitoring, project leadership and

Learn more about Gunnar >

Jean Yves  Cotin photo
Belgium flag Belgium

Jean Yves Cotin

Director Clinical Quality Assurance at UCB

Jean Yves holds PhD in Pharmaco-Toxicology. He started as a researcher at the University, then joined the Pharma industry as a Toxicologist, then as a Project Leader for the development of New Drugs b

Learn more about Jean Yves >

Franck Schwartz photo
Switzerland flag Switzerland

Franck Schwartz

QA, Global Inspection, Intelligence Lead Compliance and Regulatory Affairs at Novartis

Franck Schwartz has got a MD degree on 1989. After having practiced the medicine as a general practitioner for two years, he joined the Ipsen Group in 1992. He spent more than twenty years in the comp

Learn more about Franck >

Roberta  Tucker photo
United Kingdom flag United Kingdom

Roberta Tucker

Senior Director Global Quality Assurance at Norgine

Senior Director Global Quality Assurance at Norgine where she is responsible for governance and quality systems across all GxPs through from development to commercialisation. A Senior QA professiona

Learn more about Roberta >

Meet the advisors

Principal QA Specialist,
Leo Pharma, Denmark

Birthe Emilie Nielsen

Agency for Medicine and Medical Devices, Serbia

Violeta Ristic

R&D Clinical & Medical Quality Operations
Sanofi, France

Heiner Gertzen

QA Manager,
Zambon, Italy

Anna Piccolboni

Want to know more?

Who should attend

BY POSITION

SVPs, VPs, Heads, Directors of:
- Clinical Quality Assurance
- Clinical Auditing
- Medical Quality
- Clinical CAPA
- Clinical Data Quality
- GCP Compliance
- Clinical Quality Project Management
- GCP Auditors
- Clinical Quality Monitoring, Metrics
- Clinical Process Management

BY INDUSTRY

  • Pharma & Biotech companies
  • Regulatory and competent authorities
  • Investigators
  • Associations
  • Service & solution providers

What do the attendees say

  • 'Really great conference, interesting agenda and high quality speakers”

    Anne Ghent

    Global Head R&D Quality, Amgen, UK

  • 'Excellent opportunity to discuss common problems and possible solutions with peers from pharmaceutical & CRO industry. Well organized and very well structured with several interactive opportunities. “

    Anne Smith

    CQA Manager, GW Pharma

  • “Excellent conference, overall, the best I ever attended.”

    Gabriele Remp

    Head Clinical Quality Assurance, Austria

  • "I really enjoyed the event, thank you for the excellent organization !"

    Heiner Gertzen

    Sanofi

  • "I would like to thank you for a very professional meeting; I really enjoyed meeting the other delegates and having some excellent discussions"

    Birthe Emilie Nielsen

    Principal QA Specialist, Leo Pharma

  • “Very well organized, good speakers and interesting topics.”

    Fabio Miceli

    Associate Director Country Clinical & Quality, Norgine

  • "The first edition of the clinical quality & compliance masterclass is really a success, with the quality of presentations, format of the event and seniority of participants.”

    Sabine Glibert

    Lead & Comply, Belgium

Partners

Endorsing Partner

Media Partner

Media Partner

Media Partner

Media Partner

Media Partner

Media Partner

Join us in Prague

NH Prague City Hotel
Tel.: +420 257 153 111
Mozartova 261/1 15000 Prague
Visit hotel's website

Prague, the capital and the largest city of the Czech Republic, is situated on the Vltava river. It is nicknamed "the City of a Hundred Spires" and famous mostly for its Old Town Square with the medieval Atronomical Clock and colorful baroque buildings and Gothic churches. Prague is ranked sixth in the Tripadvisor world list of best destinations in 2016 and is popular tourist destination.