News

Delphine Decker will present on the Regulatory Requirements for Clinical Trial Application in the EU during the 3rd Annual Clinical Trials Asia Summit 2012 in Mumbai, India on February 9, 2012. Delphine’s presentation will in particular cover the Voluntary Harmonization Procedure, an initiative aimed at resolving the disparities that exist among the various EU Member States, both in terms of protocol design and timelines for the review of the clinical trial application.

Please contact vcbangalore@voisinconsulting.com or the Event’s page for more details.

13 December 2011: New EU food labeling rules comes into force

The New Food Information Regulation (EU) No 1169/2011 (FIR) of the European Parliament and of the Council of 25 October 2011 comes into force with new rules amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, repealing the Food Labeling Directive 2000/13/EC and the Nutrition labeling Directive 90/496/EC as well as the Commission Directive 87/250/EEC, Commission Directive 1999/10/EC, of the European Parliament and of the Council, Commission Directives2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004.

The regulation, applicable in all EU member states, has in-built transition arrangements meaning that a number of the requirements will not apply until 2014 while Nutrition labeling will only become mandatory in 2016. Everyone knows too well that transition periods are never long enough, and year 2014 is only just round the corner. The cost implications of incorrect labeling could be quite grave and the best advice is not to delay in making a plan to ensure compliance while there is still some time flexibility. Such plan will entail a subtle review of existing product labels and/or development of new product labels in compliance with the new rules in order to ensure a smooth and seamless transition to full compliance before or by the end of the transition period.

In case you are looking into developing a compliance plan for your food or Nutraceuticals/Nutricosmetics products, or with validating compliance with the new rules, we’ll be happy to provide the needed support. Simply send an electronic copy of your product label(s) for pertinent compliance check and initial advice.

Contact vclausanne@voisinconsulting.com for more details.

Sylvie Le Gledic and Anne Dupraz will present on the Practical Implications of the EU InVitro Diagnostic Directive Recast as well as on the Regulatory Requirements in the EU to Support MedTech Innovation during the Regulatory Education and Networking event organized by the Regulatory Affairs Professionals Society (RAPS) Switzerland Chapter in Lausanne on December 15, 2011.

Please contact vclausanne@voisinconsulting.com or consult the event’s page on RAPS website for more details.

An article entitled Biomarker Qualification: a First Step Towards Companion Diagnostic Development authored by Voisin Consulting Life Sciences is now available in the November 2011 issue of the Regulatory Affairs Journal. It provides an analysis of the current regulatory framework surrounding biomarker qualification in the EU and US, including their development in some cases as companion diagnostics.

Contact vcrennes@voisinconsulting.comfor more details.

We are pleased to announce the opening of our office in Canary Wharf, London (see address and contact point). This new location adds the United Kingdom to VCLS’ network of connected operations that include Cambridge (MA, USA), Lausanne (Switzerland), Paris and Rennes (France), Bangalore (India) and Singapore. In the interest of our clients, this new office is located close to the European Medicines Agency as a result of the expansion of the team as well as the need for improved logistical capabilities for our meetings with the Agency.

Frédéric Pailloux will present on Regulatory Hurdles & Challenges in Drug development during the Swiss Biotech Academy conference entitled Adding Value to your Drug Development Process to be held on November 9th, 2011 in Bern, Switzerland. This conference aims at providing Small- to Mid-size enterprises with an overall picture of the regulatory requirements and marketing strategies, with the objective to prevent costly and time-consuming mistakes in make-or-buy decisions. Frédéric’s presentation will focus on the necessity to approach Regulators at early stage in Drug Development.

Please contact vclausanne@voisinconsulting.com for more details.

Sabah Malek will present on Co-Development of Targeted Therapeutics and Companion Diagnostics with FDA during the World Companion Diagnostics Summit in Boston, MA held on November 28th, 2011. This workshop will focus on the major regulatory issues that concerns diagnostic and pharmaceutical partners during co-development including the development process, coordination of clinical trials, FDA review of both products, and the impact of the recently proposed draft guidance on both sides of the industry.

Please contact vccambridge@voisinconsulting.com for more details.