Regulatory Peculiarities

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Combination Products and Companion Diagnostics

The regulatory pathways for medicinal products (drugs) on the one hand and medical devices / in-vitro-diagnostics on the other are different and separate from each other. When a medicinal product is meant to be used in combination with a medical device, or when a diagnostic test needs to be performed to support the choice of the right medication, special rules apply that impact your regulatory strategy from the beginning. Dr Manja Epping and Christoph Behm will guide you through typical scenarios and strategic options.

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Expertise

Branchen

Life Sciences & Healthcare

Speaker

Sarah Turner

Senior Knowledge Lawyer

London
+44 20 7300 7000
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Louise Millot

Associate

Paris
+33 1 72 74 03 33
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Michiel Boer

Michiel Boer

Partner

Amsterdam
+31 88 02 43 264
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Julie Chiu

Senior Counsel

London
+44 20 7300 7000
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Richard Faichney

Richard Faichney

Partner

London
+44 207 300 4773
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Ján Lazur

JUDr. Ján Lazur, LL.M.

Partner

Bratislava
+421 2 5263 2804
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Charlie Madill

Associate

London
+44 20 7300 7000
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Xiaowen Paulus-Ye

Xiaowen Paulus–Ye

Partnerin

Hamburg
+49 40 36803 0
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Stefanie Engmann, LL.M. (Northwestern)

Senior Associate

München
+49 89 21038 0
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Laura Coucke

Laura Coucke

Senior Associate

Brüssel
+32 2 3202 260
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Rica Nauschütte, LL.M. (Medizinrecht)

Associate

Düsseldorf
+49 211 8387 0
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Louisa Penny

Senior Counsel

London
+44 20 7300 7000
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Fritz-Ulli Pieper

Fritz–Ulli Pieper, LL.M.

Salary Partner

Düsseldorf
+49 211 8387-240
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Boris Smit

Boris Smit

Associate

Amsterdam
+31 88 024 3272
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Shaquila Sewratan

Shaquila Sewratan

Associate

Eindhoven
+31 88 02 43 251
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Benjamin Znaty

Benjamin Znaty

Counsel

Paris
+33 172 74 03 33
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Geraerts-Marnix

Marnix Geraerts

Partner

Amsterdam
+31 88 02 43 219
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Abigail Reynolds

Senior Associate

Cambridge
+44 1223 446 400
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Manon van Weezel

Manon van Weezel

Associate

Eindhoven
+31 88 02 43 123
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Alexandra Boreham

Alexandra Boreham

Associate

London
+44 20 7300 7000
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Bram Nijhof

Bram Nijhof

Partner

Eindhoven
Brüssel
+31 88 02 43 113
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Rica Nauschütte, LL.M. (Medizinrecht)

Associate

Düsseldorf
+49 211 8387 0
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Steffen Brohm

Professional Support Lawyer

Hamburg
+49 40 36803 0
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James Homan

James Homan

Partner

London
+44 20 7300 4124
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Christian Tenkhoff

Dr. Christian Tenkhoff

Partner

München
+49 89 21038 0
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Abigail Reynolds

Senior Associate

Cambridge
+44 1223 446 400
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Emile Vanrobaeys

Emile Vanrobaeys

Associate

Brüssel
+32 2 320 22 53
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Diptanil Debbarma

Dr. Diptanil Debbarma

Counsel, European Patent Attorney

Amsterdam
+31 88 02 43 209
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Juliane Dost

Juliane Dost, LL.M. (Medizinrecht)

Salary Partnerin

Düsseldorf
+49 211 8387 0
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Nicholas Vollers

Associate

London
+44 20 7300 7000
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Richard Faichney

Richard Faichney

Partner

London
+44 207 300 4773
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Natasha Zahid

Partner

Dubai
+971 43 09 1023
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Christopher Bakier

Mag. Christopher Bakier

Senior Associate

Wien
+43 1 71 65 50
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Bryce Bartlett

Senior Associate

London
+44 20 7300 7000
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Dr. Gunbritt Kammerer-Galahn

Partnerin

Düsseldorf
+49 211 8387 0
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Ian Moore

Partner

London
+44 20 7300 4664
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Kim Wedral

Partner

Cambridge
+44 1223 446 400
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Charlie Adams

Charlie Adams

Senior Counsel

Cambridge
+44 1223 446 400
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Holger Schrewe

Dr. Holger Schrewe, LL.M. (London)

Partner

Hamburg
+49 40 36803 0
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Agnieszka Wardak Search Result

Agnieszka Wardak

Partner

Warschau
+48 22 584 97 40
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Events

HR Coffee Break Life Sciences Banner

Recalibrating EU Medical Device Regulation: Deep Dive into the EU MDR / IVDR COM-Proposal

Online
18. März, 10:00 - 11:00 CET
Speaker Dr. Wolfgang Rehmann & Irina Rebin

PZ-Management-Kongress

in Präsenz
25. März
Speaker Dr. Martin Jäger
HR Coffee Break Life Sciences Banner

Product Liability meets Mass Claims

Online
15. April, 10:00 - 10:30 CET
Speaker Florian Lambracht & Irina Rebin

FemTech – Gendersensible Medizin im Fokus

in Präsenz
22. Juni, 17:00 - 19:00 CEST
Speaker Dr. Amir-Said Ghassabeh & Dr. Carolin Monsees, CIPP/E
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