March 2012
An article entitled US and EU regulations for drug delivery systems: development considerations for innovative products authored by Voisin Consulting Life Sciences is available in the February 2012 issue of Scrip Regulatory Affairs. It provides an analysis of the current regulatory framework and challenges surrounding development and registration of innovative combination of drug and delivery system in the EU and US.
Contact vcrennes@voisinconsulting.com for more details.
March 2012
Emmanuelle Voisin, Anne Dupraz-Poiseau, Valérie Pimpaneau, Delphine Decker and David Uguen are currently attending the DIA EuroMeeting in Copenhagen.
Contact vcparis@voisinconsulting.com if you want to arrange a meeting or meet them during the following sessions:
February 2012
Voisin Consulting Life Sciences continues to be actively involved in the Drug Information Association EuroMeeting. This year, it will gather stakeholders and professionals of healthcare and life sciences innovation in Copenhaguen, Denmark, from 26 to 28 March. Our team is in charge of conference tracks organization, and will chair sessions and present on various topics: the setup of multinational clinical studies, the development of biobetters, the challenges of developing cell, gene and tissue therapy products, and the design a chemistry, manufacturing and controls strategy for such complex products. We all look forward to meeting you there!
Contact vcparis@voisinconsulting.com if you want to arrange a meeting or know more about the topics we will comment on.
January 2012
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.
December 2011
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.
October 2011
VCLS has submitted comments on the FDA’s recently issued draft guidance document on in vitro companion diagnostics (CDx). This draft guidance document aims at assisting sponsors who are planning to develop a targeted therapeutic and in vitro companion diagnostics. The FDA clarifies the co-development and approval of these two products as well as provides labeling and marketing recommendations.
October 2011
Marielle Fournier and Sylvie Le Glédic recently presented on Telemedicine and E-Health Systems at the International Workshop on Future Wellness and Medical Information and Communication Technology (ICT) Systems in Brest (France). The presentation focused on telemedicine products and the related challenges for developing and obtaining market approval. Marielle and Sylvie covered the interface between regulators, industry and users/patients, as well as the following regulatory issues: product quality, the demonstration of safety and performance-efficacy, data robustness, the identification of adequate endpoints and comparator in view of price and reimbursement negotiations.
Please contact vcrennes@voisinconsulting.com for more details.
October 2011
Christophe Amiel recently presented at the MEDevice Europe conference in Barcelona, Spain on Regulatory requirements in the EU to support MedTech innovation. Christophe’s presentation treated of key strategic steps of medical device development and efficient management of risks, illustrated with practical case studies in relation with innovative medical devices, drug/device combination products and nanotechnologies.
Please contact vcboulogne@voisinconsulting.com for more details.
October 2011
VCLS recently submitted comments on the FDA’s recently issued draft guidance document on in vitro diagnostics (IVDs). This FAQ document clarifies industry practices for research use only (RUO) and investigational use only (IUO) and provides an interesting perspective on FDA’s view on labeling, marketing, and Quality Systems requirements.
October 2011
Voisin Consulting Life Sciences recently published an article discussing paediatric clinical investigations for Cell, Gene and Tissue-engineered medicinal products in the October issue of the Regulatory Rapporteur. This article, based on VCLS’ experience with Advanced Therapy Medicinal Products, comments on how the particular nature of such ‘unconventional’ products must be taken into account for designing adequate paediatric investigation plans.
December 2011
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.
November 2011
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.
November 2011
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.
November 2011
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.
November 2011
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.
June 2011
Tim Adetona will present on the Regulatory Trends important for Indian Exports – 100% compliance at the forthcoming FICCI-HADSA 3rd International conference on Nutraceuticals, Functional Foods and Dietary Supplements on June 23, 2011 in Mumbai, India. Tim will speak on the importance of incorporating pertinent regulatory consideration early in the development of such products. Please contact vcbangalore@voisinconsulting.com for more details.
July 2011
The FDA announced earlier this week the release of the much anticipated draft guidance document on in vitro companion diagnostic devices, which are to be used in conjunction with targeted therapeutics. The co-development aspects and lack of regulatory framework has made developing these personalized medicine products challenging for both diagnostic and pharmaceutical companies. The draft guidance addresses the following:
VLCS looks forward to commenting on this draft guidance.
June 2011
Emmanuelle Voisin and Anne-Virginie Eggimann will attend the 2011 BIO International Convention on June 27-30 in Washington, DC. If you wish to meet with them during the conference, please contact us.
May 2011
Anne Dupraz-Poiseau and Linda Lebon will attend the ILSI BioMed 2011 in Tel Aviv on May 23-25, 2011. They will be pleased to meet you there and discuss your product development and regulatory matters. Do not hesitate to contact us if you wish to arrange a meeting.
Recently, Linda Lebon attended the 2011 IPSOR meeting in Herzliya that focused on making the bridge between health care product development and pharmaco-economic processes. Voisin Consulting also attended the IsraMedTech conference in Haifa on Mach 2011.
Both Linda and Anne are familiar with the Israeli culture and experts in global strategies for health care product development anticipating return on investment.
March 2011
Sylvie Le Glédic and Christophe Amiel will attend the 12th MedTech Investing Europe Conference in Lausanne on March 7 & 8, 2011. If you wish to meet with them, please contact us.
March 2011
Emmanuelle Voisin (Principal), Mihaela MacNair, Larisa Nagra Singh and Frederic Pailloux (General Managers of Voisin Consulting Life Sciences in US, India and Switzerland respectively) will attend the DIA 23rd Annual EuroMeeting on 28-30 March in Geneva. Larisa Nagra Singh will chair a session on Transforming Indian Regulatory Environment and its Impact on Clinical Development. If you wish to meet with them during the Conference, please contact us.
February 2011
Tim Adetona will be presenting on Harmonization of International and Indian Regulatory framework at the 6th Nutra India Summit that takes place in Mumbai, India on February 15-18, 2011. Please contact vcbangalore@voisinconsulting.com for more details.
January 2011
Dr. Anne Dupraz-Poiseau and Anne-Virginie Eggimann will participate in the Phacilitate’s 7th annual Cell & Gene Therapy Forum 2011 that takes place in Washington DC on January 24-26, 2011. They will be chairing a workshop on stem cells development. If you wish to meet with them during the Forum, please contact us at vccambridge@voisinconsulting.com.
January 2011
Laboratoires CTRS and Voisin Consulting Life Sciences (VCLS) are pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion recommending the granting of a marketing authorisation for CTRS’ product Orphacol (cholic acid) for the treatment of inborn errors in primary bile acid synthesis. This positive outcome for a life-saving, ultra-orphan drug is a result of a close collaboration: VCLS has assisted CTRS in the preparation of the application dossier and has compiled the eCTD. VCLS also had a significant role in all steps of the approval procedure itself. The positive opinion with details on the product and the procedure are available here
Season’s Greetings !
This year, we prepared a short movie that will take you to one of Voisin Consulting Life Sciences daily moments. We hope you will enjoy it.
November 2010
The article entitled "Biosimilars in the EU: Nonclinical and Early Clinical Development” prepared by Voisin Consulting Life Sciences is now available in the November 2010 issue of Drug Information Journal. It provides an overview of the current regulatory framework, applicable guidelines and key stakeholders in the EU regulatory environment for Biosimilars.
October 2010
Voisin Consulting Life Sciences will attend the 2010 BIO-Europe conference in Munich, Germany on November 15-17. Feel free to contact us if you wish to set up a meeting with us.
September 2010
Voisin Consulting Life Sciences recently published an article discussing “EU Compassionate Use Programmes (CUPs) Regulatory Framework and Points to Consider Before CUP Implementation” in the September 2010 issue of the Pharmaceutical Medicine Journal. This article is based on the experience gathered so far by VCLS with the Compassionate Use Programmes.
Combination Product Congress
Please take note of VCLS active participation in two conferences on combination products regulations, including combined ATmP:
July 2010
The Therapeutic Goods Administration (TGA) will officially launch a new organisational structure on 1 July 2010. The TGA`s offices will be arranged in three groups, based on their area of regulatory oversight:
The TGA has already implemented several reforms aimed at enhancing the transparency of regulatory decision making. Notably, the publication of Australian Public Assessment reports (AusPARS), detailing the risk benefit analysis undertaken by the TGA in deciding to regulate new prescription medicines. Similarly, since November 2009 the TGA has published Product Information and Consumer Medicines Information on its Internet site.
Importantly, the TGA`s main contact points will remain as they are at this time. Please continue to liaise with your current TGA contacts for any day-to-day business needs.
June 2010
ORCA, the Organization of Regulatory and Clinical Associates and TOPRA, the Organization for Professionals in Regulatory Affairs, host an Event on the key EU regulatory developments considerations, including the Scientific Advice and Pediatric Development processes, an update on EMA/FDA joint initiatives and a panel discussion of participant questions. Anne-Virginie Eggimann will be presenting “Industry perspective on Pediatric Development Review, including lessons learned”. The event will take place in Seattle, WA on June 23, 2010.
June 2010
NIH, FDA Coordinate Efforts to Support Personalized Medicine: Writing in the New England Journal of Medicine, the heads of the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) laid out their plans to help expedite the development of gene-therapy drugs and diagnostics for personalized medicine. In their commentary, FDA Commissioner Margaret Hamburg and NIH Director Francis Collins committed their agencies to investing in efforts to establish a clear regulatory path for both drugs and diagnostics that encourages innovation while ensuring patient safety. More.
May 2010
The IRS has released guidance on the new Therapeutic Discovery Project Program passed as part of the Patient Protection and Affordable Care Act.
The credit will cover up to 50 percent of the cost of qualifying biomedical research, up to a maximum credit of $5 million per business. The credit is available to companies with fewer than 250 employees and for investments made in 2009 and 2010. The benefit is also available in the form of a grant, for those companies which would not qualify for a tax credit.
May 2010
Camille Métais recently published an article discussing “How to optimally integrate a Paediatric Investigation Plan into a drug development programme” in the May 2010 issue of the TOPRA Regulatory Rapporteur. This article is based on the experience gathered so far by Voisin Consulting with the Paediatric Investigation Plan. To read Camille Métais’s article, please use this link.
May 2010
Anne-Virginie Eggimann and Eric Lawson will be attending the BIO 2010 International Convention in Chicago, IL May 3-6.
Eric will be hosting a panel of FDA and industry experts on the Hot Topic of Companion Diagnostic regulatory pathways. The panel discussion will be focused on how to co-develop drug/ biologics with diagnostics, and emphasize the need for partnership between industry and regulators in this rapidly evolving field.
Anne-Virginie will be a panel member exploring the topic of “Development Strategies for Novel Drugs and Biologics: Doing it Right the First Time”. The panel will outline a practical example of designing and obtaining worldwide regulatory acceptance of the development program for a novel therapeutic.
Anne-Virginie and Eric hope to see you in the audience of each session and welcome the opportunity to meet with you during the conference. If you wish to pre-arrange a meeting with them please do so by clicking on their name. Enjoy BIO 2010!
March 2010
In the January 2010 issue of Pharmabio World journal, Stephan Reynier authored an article entitled "Overview of the EU CTA Regulatory Framework and Future Direction of the EU Clinical Trial Directive". The article is available here.
April 2010
Swissmedic announced that it has signed an MOU between regulatory agencies in Australia (Therapeutic Goods Administration, TGA), Canada (Health Canada) and Singapore (Health Sciences Authority, HSA) to form a network to look into initiatives to facilitate market access and surveillance for pharmaceutical products in these countries. In a first major step, there will be regular meetings at the Heads of Agencies level and applications for new pharmaceuticals will be reviewed in tandem – HC-TGA / Swissmedic-HSA.
These reviews will be shared with the agreement of the applicant to aid in the exchange of experience and practices, however, the conclusions on the application may differ still. Going forward, these regulatory agencies will move towards the direction of significant collaboration and worksharing with close similarity to the EU MRP/DCP model. In line with Voisin Consulting’s mission to offer innovative regulatory strategies for emerging biotechnology and pharmaceutical companies through an international approach, our offices are ideally located in 3 out of 4 of these countries to optimise these developments. More information may be found here (press release).
February 2010
May Ling Chan recently attended the first Partnerships in Clinical Trials Asia Pacific conference and contributed a conference report which has been published recently on actmagazine.com. Her take on the conference and the pros and cons of including the Asia-Pacific region in global clinical trial programs are also featured in a blog by the same magazine. Please click on the article and blog to read more.
January 2010
Dr. Emmanuelle Voisin was recently interviewed by Vivek Roychowdhury from ExpressPharma about building an affordable, innovative drug development chain, from discovery to market with the skilled people & partners of India. To read more about this insightful interview, please follow this link.
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