Publications and presentations

Publications

A&O alerts

China Further Encourages the Marketing Authorisation Holder Regime – 12 September 2017, by Victor Ho and David Shen

“Sunshine” in Belgium: New Statutory Transparency Requirements for Life Sciences Companies – 5 September 2017, by Geert Glas, Eveline Van Keymeulen and Tine Carmeliet

Regulating CRISPR genome editing in humans: where do we go from here? – 31 August 2017, by Eveline Van Keymeulen, Erin Currie, Audrey Aboukrat, Rafi Allos and Marco de Morpurgo

Government Registration Requirement for Medical Representatives in Shanghai – 31 August 2017, by David Shen

Falsifying Drug Regulatory Submission May Be a Criminal Offence in China – 28 August 2017, by David Shen

Generic Consistency Evaluation in China: The Coming Paradigm Shift in Drug Pricing and Patent Cliff – 18 April 2017, by David Shen and Jill Ge

China issues bill amending Law Against Unfair Competition – 22 March 2017, by David Shen

Importance of patents in Chinese pharmaceutical tendering – 14 March 2017, by David Shen

Round one of the the U.S. CRISPR patent battle is over – but what does the PTABS’s no interference-in-fact decision really mean?– 1 March 2017, by Daniel Lim, Dr Joachim Feldges and Nicola Dagg

How the legislator restricted the export of medicinal products – November 2016, by Juraj Gyarfas

EU Court of Justice Outlaws German Fixed Retail Pricing System for Prescription Medicines – 25 October 2016, by Marco de Morpurgo and Alexandre Rudoni

Excessive prices in the pharmaceutical industry: the Aspen case – 25 October 2016, by Emilio De Giorgi

Cybersecurity in life sciences: what is your duty of care? – 26 July 2016, by Nicola Dagg, Filip Van Elsen, Alexandre Rudoni, Mark Ridgway and Mark Mansell

Big Brother wants to see you: Obligatory disclosure of monetary and non-monetary considerations – 18 December 2015, by Juraj Gyarfas

EMA Consults Stakeholders on the Practical Application of Clinical Trial Data Transparency – 10 September 2015, by Laëtitia Bénard, Eveline Van Keymeulen and Marco de Morpurgo

Ensuring data protection in the implementation of the EFPIA Disclosure Code: Key challenges and how pharmaceutical companies are addressing them – 27 February 2015, by Nigel Parker and Eveline Van Keymeulen

New Clinical Trial Rules in the EU: A First Overview – 3 June 2014, by Laëtitia Bénard, Eveline Van Keymeulen and Marco de Morpurgo

Biosimilar Substitution in France: No Way Back? – 8 January 2014, by Laëtitia Bénard, Alexandre Rudoni and Eveline Van Keymeulen

Pharmaceutical companies face new pharmacovigilance obligations in the EU – 10 November 2013, by Alexandre Rudoni, Laëtitia Bénard and Eveline Van Keymeulen

The EFPIA transparency initiative: Making hay while the sun shines? – 10 October 2013, by Alexandre Rudoni, Laëtitia Bénard and Eveline Van Keymeulen

France issues “good dispensing practices” for online sales of medicines – 19 July 2013, by Alexandre Rudoni, Laëtitia Bénard and Eveline Van Keymeulen

Transparency requirements under the French Sunshine Act: Life sciences companies in the dark? – 11 June 2013, by Alexandre Rudoni, Laëtitia Bénard and Eveline Van Keymeulen

Published work

Crowded field – Intellectual Property Magazine, 5 December 2017, by Daniel Lim

From Takeda to Teva v Merck: Are We Treading the Right Path on Combination Product SPCs? (Part 2) – (2017) 39 (11) E.I.P.R. 697-704, by Nicola Dagg, Steven Baldwin and Dr Tony Rollins

‘Sunshine’ in Belgium: New Statutory Transparency Requirements for Life Sciences Companies, European Pharmaceutical Law Review (EPLR), October 2017, by Eveline Van Keymeulen and Tine Carmeliet

The revised French transparency regime: additional disclosure obligations for life sciences companies, Practical Law (Thomson Reuters), October 2017, by Eveline Van Keymeulen and Laëtitia Bénard

The definition of product in the SPC Regulation: (Part 1 of 2) What’s in a name? – (2017) 39 (9) E.I.P.R. 555-564, by Nicola Dagg, Steven Baldwin and Dr Tony Rollins

The European Court to rule on milestone in European GMO legislation: the legal classification of mutagenesis in plant breeding – Bio-Science Law Review, June 2017, by Geert Glas and Tine Carmeliet

The expected future ubiquity of consumer virtual reality equipment and consequent legal and regulatory challenges – Lamy magazine, December 2016, by Alexandre Rudoni and Emil Albihn

The Nutrition and Health Claims Regulation Applies to Commercial Communications Addressed to Health Professionals – European Journal of Risk Regulation, October 2016, by Marco de Morpurgo and Patricia Carmona Botana

Court of Justice of the EU anchors market exclusivity for orphan medicinal products (annotation of Cases T-140/12 and C/138/15P) – Jurisprudentie Geneesmiddelenrecht (in Dutch), July 2016, by Eveline Van Keymeulen

Brexit: Time is of the essence for life sciences innovators – Life Sciences Intellectual Property Review, 30 June 2016, by Laëtitia Bénard

Parallel Trade in the Slovakian Pharma Sector: Between Hammer and Anvil – CEE Legal Matters, 3 September 2015, by Martin Magal and Juraj Gyarfas

Digital Health in the EU: Moving “beyond the pill” – mHealthNews, January 2015, by Filip Van Elsen, Eveline Van Keymeulen, Quentin Van Peteghem and Julie Bossaert

La vente des lunettes “sous la loupe” (The sale of glasses “under the magnifying glass”) – Le Monde du Droit, May 2014, by Eveline Van Keymeulen and Alexandrine Ananou

France’s biosimilar law may set trend inside the EU – LAW 360 (a LexisNexis company), February 2014, by Laëtitia Bénard and Eveline Van Keymeulen

The proposed EU device regulation: A look on the – possibly – bright side – SCRIP Regulatory Affairs, June 2013, by Eveline Van Keymeulen

Specific provisions for medicines in J. Ysewyn, M. Van Schoorisse a.o., The Belgian Competition Act 2013 (in Dutch), Antwerp, Intersentia, 2013, by Eveline Van Keymeulen

Presentations

Brexit: Regulatory and IP Consequences for the pharmaceutical industry – March 2017, by Nicola Dagg

Transparency of Clinical Trial Data: The New [Clinical Trials] Regulation and its Interaction with the EMA Transparency Policies – 25 Novembre 2015, by Eveline Van Keymeulen and Marco de Morpurgo