REACH, Lebensmittel- und Pharmarecht
Conference | 27.02.2019 | Basel | Sprache: englisch

Big Data in the Pharmaceutical Sector between Protection and Transparency: Opportunities and Legal Challenges

Data in the healthcare and pharmaceutical sector play an important role in various aspects. Data has already transformed many facets of the sector. Huge datasets are driving new drug discoveries and are making clinical trials more efficient. Wearable devises such as sleep trackers are creating more informed patients and the employment of more sophisticated data models has enabled healthcare professionals better to predict and prevent illness. From personalised medicine to AI assisted diagnostics and genetic engineering and sequencing, the possibilities, it seems, are endless.

However, despite its potential to improve patient care and the share price of pharmaceutical companies, legal and regulatory challenges remain. One need to look no further than the recent introduction of the General Data Protection Regulation (GDPR) to realise that significant regulatory challenges exists. With patients and regulatory becoming increasingly cognizant of data protection issues, regulatory restrictions are only going to increase.

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Methodology

This one-day conference is specifically designed to help you navigate these challenges and recognise opportunities. Aimed at practitioners, regulators and academics alike, this event will help to avoid legal pitfalls and embrace opportunities as the healthcare sector enters into the era of big data.

During the conference the following topics will be discussed:

  • Big data in the pharmaceutical sector – Current developments and legal challenges
  • Data protection issues resulting from personalized medicine and pay for performance (P4P)
  • Regulator’s standpoint
  • Using data to reduce the number of clinical trials: Regulatory issues
  • The case for ‘open source’ pharma
  • How eliminating data silos will democratize pharma R&D
  • Blockchain and datasharing in the pharma sector

Who should participate?

  • Inhouse Legal Counsel
  • Compliance and Data Protection Officer
  • Regulatory Affairs Officer
  • Life Science Attorneys
  • Regulators
  • Academics
  • Researchers

Mittwoch, 27. Februar | 08:30 - 17:15

Tagungsleiter
Claudia Seitz Faculty of Law, University of Basel, Center for Life Sciences Law (CLSL)
08:30

Registration & Welcome Coffee

09:00

Welcome Notes by Scientific Chair of the Conference


Morning Session

09:15

Keynote

Building a Swiss Personalised Health Network
(SPHN)

Torsten Schwede Vice Rector Research of University of Basel, and Director of the Personalized Health Informatics Group at SIB Swiss Institute of Bioinformatics, Bern
09:45

Transparency and Consent in the Era of Big Data Analysis and Personalized Medicine

Maria Chiara Atzori Head Data Privacy, Novartis International AG, Basel
10:15

Legal Considerations: Cell & Gene Therapies

Marieke Jansen Head of Legal C&G Europe, Novartis
10:45

Coffee Break

11:15

Big Data Applied to the Pharma Sector: Privacy vs. Transparency in the Light of the GDPR

Joaquin Cayon De Las Cuevas University of Cantabria and Director of a research group on health law and bioethics (GRIDES) at IDIVAL
11:45

Regulatory Challenges and Opportunities in the Age of Big Data

Nikolai Brun Director of Division of the Medical Evaluation & Biostatistics Division (Danish Medicines Agency) and Chair of the HMA/EMA Joint Task Force on Big Data, Copenhagen 
12:15

Discussion Round

12:45

Lunch Break & Networking


Afternoon Session

14:00

Artificial Intelligence, Data Protection and Pharmaceutical Data

Claudia Seitz Faculty of Law, University of Basel, Center for Life Sciences Law (CLSL)
14:30

CTD Transparency and Commercial Confidentiality according to the CJEU Case Law

Timo Minssen Faculty of Law and the Founding Director of UCPH's Center for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen
15:00

Coffee Break

15:30

Informational Self-determination: Patient‘s Individual
and Global Perspective

Philipp do Canto Member of the Board and the Scientific Advisory Board of the Swiss Multiple Sclerosis Association (Schweizerische Multiple Sklerose Gesellschaft, SMSG), Zurich
16:00

Real World Data – Access, Lawful Use, Value, Control and Ownership

Florian Zabel Chief Privacy Officer, Roche Group at F. Hoffmann-La Roche Ltd., Basel
16:30

Discussion Round and Panel Discussion

[Representatives from Academia, Pharmaceutical Companies, Authorities, Patient Associations]
17:15

Closing & End of the Conference


*Programme may be subject to change.

Referenten

Claudia Seitz
Faculty of Law, University of Basel, Center for Life Sciences Law (CLSL)

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Torsten Schwede
Vice Rector Research of University of Basel, and Director of the Personalized Health Informatics Group at SIB Swiss Institute of Bioinformatics, Bern

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Maria Chiara Atzori
Head Data Privacy, Novartis International AG, Basel

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Marieke Jansen
Head of Legal C&G Europe, Novartis

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Joaquin Cayon De Las Cuevas
University of Cantabria and Director of a research group on health law and bioethics (GRIDES) at IDIVAL

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Nikolai Brun
Director of Division of the Medical Evaluation & Biostatistics Division (Danish Medicines Agency) and Chair of the HMA/EMA Joint Task Force on Big Data, Copenhagen 

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Timo Minssen
Faculty of Law and the Founding Director of UCPH's Center for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen

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Philipp do Canto
Member of the Board and the Scientific Advisory Board of the Swiss Multiple Sclerosis Association (Schweizerische Multiple Sklerose Gesellschaft, SMSG), Zurich

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Florian Zabel
Chief Privacy Officer, Roche Group at F. Hoffmann-La Roche Ltd., Basel

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Partner

University of Basel - Faculty of Law

Tagungsort

Peter-Merian Weg 8
Basel, Schweiz
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Conference | 27.02.2019 | Basel | Sprache englisch
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Ticket-Typ Preis Plätze
Big Data in the Pharmaceutical Sector between Protection and Transparency: Opportunities and Legal Challenges
Regular fee / Reguläre Teilnahmegebühr
€695,00
Big Data in the Pharmaceutical Sector between Protection and Transparency: Opportunities and Legal Challenges
Reduced fee for public authorities / Reduzierte Teilnahmegebühr für Angehörige einer Behörde
€525,00
Big Data in the Pharmaceutical Sector between Protection and Transparency: Opportunities and Legal Challenges
Reduced fee for full-time academics / Reduzierte Teilnahmegebühr für Angehörige einer Hochschule
€525,00
Big Data in the Pharmaceutical Sector between Protection and Transparency: Opportunities and Legal Challenges
Reduced fee for PhD students / Reduzierte Teilnahmegebühr für Doktoranden
€235,00

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