Dr. Christian Fulda focuses his practice on the pharmaceutical, biotechnology, and medical device industries. Christian advises on strategic and transformative projects and matters, drawing on his extensive operational experience with the legal issues that these heavily regulated industries face. Christian has been the lead on transformative M&A deals, bet-the-company litigation, and disruptive technological developments. His particular focus is industry convergence, including digital health, and he routinely carries out multijurisdictional projects. His industry and product life cycle experience spans from research and development through regulatory pathways and commercialization and covers aspects of IP, contracts, regulatory, compliance, as well as product safety and liability, including related disputes.
Christian is a Fellow of the International Institute for Law and Medicine and a member of BIO Germany (Regulatory Affairs Committee and Healthcare Policy Committee), Licensing Executives Society Germany (Life Sciences Working Group), the Federal Association of Pharmaceutical Manufacturers (BAH), Forum MedTech Pharma, the Middle-European Society for Regulatory Affairs (MEGRA), and the German Institution of Arbitration (DIS).
Experiência
- November 20, 2014December 4, 2014
EMA Disclosure of Marketing Authorization Data - November 13/14, 2014
Transparency: The Inevitable Emergence of an Epic Issue, panelist, Food & Drug Law Institute European Conference - October 6, 2014
BioM-Forum: IPO in the US - a reality - September 24, 2014
How to Align your Regulatory Pathway for Marketing Authorisation of your Drug with the CE marking of a Companion Diagnostic and How to Secure a Successful Companion Diagnostic Strategy, C5 EU Pharmaceutical Regulatory and Competition Conference - July 7, 2014
How pharmaceutical companies can prepare for release of confidential data by EMA and national authorities, Infotag of the German Pharmaceutical Industry Association (BPI) on the EMA Disclosure Policies - June 6, 2014
Litigation Strategies for Life Sciences Patents under the Unified Patent Court, panelist, Union-IP Congress, Workshop Life Sciences - May 19, 2014
Developing IIS Contracts & Ensuring Corporate Investment Protection, 4th Annual EU Investigator Initiated Studies Conference, Q1 Productions - May 6, 2014
The Continuing Expansion of Health Care Enforcement by U.S. and International Authorities: Key Developments and Implications for the Future - April 10. 2014
Supplementary Protection Certificates (SPC), Recent Case Law of the Court of Justice of the European Union, Opportunities for patent term extensions for the pharmaceutical Industry, German Pharmaceutical Industry Association (BPI), Patent Day - March 20, 2014
Jeopardizing Research Investments through Publication. Publication of commercially confidential information by regulatory authorities - advantage to competitors and risk for patent applications? German Pharmaceutical Industry Association (BPI), CEO Day - November 28, 2013
Predictability and Manageability of the SPC System. An Industry Perspective. German Patent and Trademark Office, SPC Roundtable - July 15, 2013
Europe's New Unitary Patent and Unfied Patent Court: Supplementary Protection Certificates Under the New System - June 25, 2013
Product Liability for Medical Devices, Forum MedTech Pharma, Market Access for Medical Devices Workshop - April 12, 2013
Companion Diagnostics - Regulatory and Reimbursement Aspects, Licensing Executives Society (LES) Meeting - January 28, 2013
The Patent-Regulatory Interface in the EU, EU Pharmaceutical Regulatory Law Boot Camp - November 29, 2012
Utilising Supplementary Protection Certificates (SPC) to Extend Your Patent Lifecycle, Biosimilars Forum 2012 - October 18, 2012
Panel Discussion on Personalized Medicine, Symposium "Biotec+ICT=New Business" - September 24, 2012
Managed Access Programs: The Regulatory Environment in the EU & RoW, Managed Access Programs Workshop at the Outsourcing in Clinical Trials Conference - September 19, 2012
Medical Devices: Product Safety and Product Liability in the US, Forum MedTech Pharma, Workshop Market Access USA - September 13, 2012
Healthcare Reforms in Key European Markets and Impact on Diagnostics, 3rd EU Diagnostic Reimbursement & Market Access Conference - July 19, 2012
Pricing and Reimbursement Considerations for Access Programs in Europe, 5th Annual Congress on Access Programs for Investigational and Pre-Launch Drugs - May 4, 2012
Biosimilars - The European Regulatory Pathway, Licensing Executives Society (LES) Meeting - February 7, 2012
Developing Drug & Diagnostic Combination Products in the EU, IVD Regulations and Performance Evaluations Conference - September 6, 2011
Impact of Pharmaceutical Reimbursement Changes on Diagnostics, European Diagnostic Reimbursement & Market Access Conference - August 4, 2011
EU Biotech and Pharma Regulations: The IP Angle, Jones Day Client Seminar on Global Patent Trends in Life Sciences - June 21, 2011
European Perspectives on Nanotechnology: Seizing Opportunities, Protecting Technology, and Avoiding Risks - 2011
Third party changes changes to IVD. The One Touch Ultra Case and Beyond, European Diagnostic Performance Evaluation and Regulatory Conference - 2010
Nanotechnologies - Opportunities and Risks: The regulatory framework for nanotechnology in Europe, JDialog Jones Day Client Seminar - 2009
Market Access for Pharmaceuticals - Impact on License Agreements, Licensing Executives Society (LES) Meeting - 2009
Liberalisation of Pharmaceutical Marketing, BPI Bayern Presentation - 2009
Liberalisation of Pharmaceutical Marketing, Jones Day Client Seminar - 2008 / 2009
New Requirements for the Distribution of Medical Devices, Seminars for Clinical Professionals - 2008
European Pharmaceutical Marketing, Jones Day Client Seminar - 2008
European Pharmaceutical Marketing, BPI Nordrhein-Westfalia Seminar - 2007
Regulatory Issues in Biotech Transactions, Bio-M
- Humboldt University (Dr. jur. 2002); Second State Examination (Berlin, 1999); Eberhard Karls University (Tübingen), University of Geneva, and Humboldt University (Berlin) (Law studies, 1991-1997; First State Examination, Berlin, 1997); Recipient, German National Academic Foundation scholarship for both law studies and Dr. jur.
- Federal Republic of Germany: all German local, district, and courts of appeal; German Federal Patent Court (BPatG); German Federal Supreme Court (BGH) in nullity appeal proceedings; German Federal Administrative Court (BVerwG); and European Unified Patent Court (UPC)
Recommended as a "leader in the field" in the area of life sciences in Chambers Europe since 2011, where he has received stellar market feedback for his pragmatism and "impressive project management skills and timely feedback" and clients praise his "extensive experience in the life sciences sector".
- Senate of Berlin (1998); Office of the Public Prosecutor, Berlin (1998); District Court of Berlin (1997-1998)
- English, French, German, Italian
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