1 Off-label Use: Current Position in the EU and U.S. - Jackie Mulryne & Mahnu Davar, Arnold & Porter Kaye Scholer LLP 1 2 Australia Clayton Utz: Colin Loveday & Greg Williams 7 3 Austria Herbst Kinsky Rechtsanwalte GmbH: Dr. Sonja Hebenstreit & Dr. Isabel Funk-Leisch 20 4 Belgium Quinz: Olivier Van Obberghen & Joris Beke 33 5 Canada Norton Rose Fulbright Canada LLP: Sara Zborovski & Ian Trimble 43 6 China Jones Day: Chiang Ling Li & Haifeng Huang 53 7 Denmark Jusmedico Advokatanpartsselskab: Jan Bjerrum Bach & Lone Hertz 63 8 England & Wales Arnold & Porter Kaye Scholer LLP: Adela Williams & Silvia Valverde 80 9 Finland Roschier, Attorneys Ltd.: Mikael Segercrantz & Johanna Lilja 95 10 France LCH Law Compliance Health: Laure Le Calve & Johanna Benichou 106 11 Germany Clifford Chance: Dr. Peter Dieners & Jan Szemjonneck 115 12 Greece Kyriakides Georgopoulos Law Firm: Irene Kyriakides & Nefelie Charalabopoulou 129 13 India Subramaniam & Associates (SNA): Hari Subramaniam & Aditi Subramaniam 139 14 Ireland Arthur Cox: Colin Kavanagh & Ciara Farrell 150 15 Italy Biolato Longo Ridola & Mori: Linda Longo & Benedetta Muscaritoli 163 16 Japan Nishimura & Asahi: Somuku Iimura & Yoko Kasai 176 17 Mexico OLIVARES: Alejandro Luna Fandino & Armando Arenas Reyes 186 18 Netherlands Life Sciences Legal: Anke E. Heezius 197 19 Norway Haavind: Hakon Austdal & Vebjorn Krag Iversen 205 20 Poland Soltysinski Kawecki & Szlezak: Dr. Ewa Skrzydlo-Tefelska & Mikolaj Skowronek 215 21 Portugal Cuatrecasas: Joana Silveira Botelho 224 22 Russia ALRUD: Anton Dzhuplin & Maria Ostashenko 233 23 Singapore Allen & Gledhill LLP: Dr. Stanley Lai, SC & Gloria Goh 242 24 Spain Baker & McKenzie: Cecilia Pastor & Ester Navas 252 25 Sweden Mannheimer Swartling Advokatbyra: Helen Waxberg & Jenny Bergstrom 265 26 Switzerland Pestalozzi Attorneys at Law: Dr. Lorenza Ferrari Hofer & Lukas Herforth 276 27 Taiwan Deep & Far Attorneys-at-Law: Yu-Li Tsai & Lu-Fa Tsai 285 28 Turkey Gun + Partners: OEzge Atilgan Karakulak & Ceren Aral Desnos 294 29 Ukraine Gorodissky & Partners (Ukraine): Nina Moshynska 306 30 USA Arnold & Porter Kaye Scholer LLP: Daniel A. Kracov & Mahnu V. Davar 316