Voisin Consulting

May 2013

Melanie — 2013-05-08T14:22:08Z

Emmanuelle Voisin, Founder and CEO of Voisin Consulting Life Sciences, will present at the 15th Shanghai International Forum on Biotechnology & Pharmaceutical Industry BIO-FORUM and Bio-Med Exhibition May 29-31, 2013 in Shanghai, China.

Emmanuelle's presentation, entitled “Forthcoming changes in medical devices & In-Vitro Diagnostics regulations in the European Union”, will comment on the evaluation and anticipated concentration of Notified Bodies, and the change of regulatory approval route for high-risk medical devices. In regards to IVDs, Emmanuelle will detail the anticipated creation of a 4-level classification of product-related risks, and the subsequent higher regulatory scrutiny that is expected for this type of healthcare products.

Emmanuelle will also chair a session on Latest Administrative Regulations: covering topics on Regulation and Policies of New Drug Approval, Medical Insurance and Market Access in China, EU and USA; and present a 20” overview on Current Developments in European Regulations.

May 2013

Melanie — 2013-05-07T21:00:35Z

Valerie Pimpaneau will be attending the EU CMC Strategy Forum May 6th to 8th in Prague. A number of critical CMC topics focused on improving the quality in development and manufacturing of biopharmaceutical products will be discussed including process validation, QbD, bioassays, change management protocols, devices and combination products.

April 2013

Melanie — 2013-04-12T15:43:53Z

Richard Dennett will be presenting a one day bioindustry workshop on Technology Transfer, Comparability and cGMP Outsourcing Strategies at the 9th Annual Bioprocess International Europe Conference & Exhibition in Düsseldorf 16th- 18th April. Richard will also be Chairing the session on optimizing the production of Fc fusion proteins.

April 2013

Melanie — 2013-04-11T17:42:53Z

Jilla K. Boulas will be chairing a panel discussion on clinical trials for biological products in the European Union, focusing on applicable requirements for Quality Documentation Concerning Biological Investigational Medicinal Products as part of a workshop organized by the Drug Information Association entitled “From Drug Development to Global Supply to Patients” (Washington D.C., April 15-17).

Chemistry, Manufacturing and Controls (CMC) specialists from industry and regulatory agencies will share experiences and perspectives on the role of CMC in this important phase of drug development.

April 2013

Melanie — 2013-04-11T16:25:40Z

Sylvie Le Gledic will present the Biomarker Qualification processes in EU and US at the Biomarkers B4B Connection that will take place in Romainville (France) on April 10th and 11th.

Sylvie will describe and comment on such qualification processes and discuss the current situation regarding qualified biomarkers.

For more details, feel free to contact us.

April 2013

Melanie — 2013-04-05T17:47:10Z

Upcoming FREE webinar: “From Genomic Biomarkers to Companion Diagnostics” presented by Patrick Larcier - Pharm.D., MBA - Senior Director of VCLS & Marc Hillairet de Boisferon, PhD - Head, In vivo Lab, of Oncodesign.

Join us for this insightful webinar on Thursday, April 25 at 8amPST; 11amEST; 5pmCET.

Learn how biomarkers are now recognized to help drug development in both preclinical and clinical settings: decision-making is based on strong science. In the first part of the presentation, we will present concrete examples of the usefulness of biological resources and preclinical models of human cancer pathologies, associated with extended clinical and preclinical data sets to identify and validate new biomarkers.

The second part of the presentation will present both the impact of the proposed draft guidance issued by the FDA and the expected major changes surrounding companion diagnostic regulation to occur in the EU, in order to give companies a clearer perspective on how to shape their internal company practices to be aligned with the latest thought process of regulators in both the US and EU.

Reserve your webinar seat now

April 2013

Melanie — 2013-04-01T13:47:26Z

Voisin Consulting Life Sciences will be attending the symposium on quality of raw materials used for the production of cell based and gene therapy products jointly organized by EDQM and EMA on April 3rd in Strasbourg, France.

This symposium is organized to bring together users and suppliers of raw materials as well as regulators and exchange experience, position and needs as it relates to quality standardization of raw materials used to manufacture cell and gene therapy products. The EDQM is planning to prepare a text covering the quality requirements of these raw materials in order to standardize and harmonize current practices. The outcome of this symposium will be important as it will help define the content of the text to be developed by the EDQM Working Group.

March 2013

Melanie — 2013-03-05T21:26:39Z

Sylvie Le Gledic and Sabah Malek will be co-presenting on the Practical Implications of the Co-Development of Targeted Therapeutics and Companion diagnostics: A Regulatory Perspective during World Companion Diagnostic Summit in Frankfurt, Germany on March 19, 2013.

March 2013

Melanie — 2013-02-25T13:51:38Z

Marielle Fournier and Richard Dennett will be presenting at the DIA 25th Annual EuroMeeting in Amsterdam (4-6 March 2013). Marielle will present on the EU rules for Telemedicine and the action which is underway to address the regulatory needs for mHealth and eHealth to encourage innovation and the impact on product development. Richard will be running an interactive workshop on the importance of technology transfer for biopharmaceuticals.

February 2013

Melanie — 2013-02-15T20:11:31Z

Richard Dennett will be presenting at the 2nd Biosimilars Congregation 2013 (February 19-20, London) on technology transfer and comparability strategies for biosimilars. Richard will discuss the important interplay between comparability and technology transfer, which acts as a determining factor in the development and realization of biosimilars. Richard will discuss how strategic leverage can be obtained from the biosimilar and ICH guidelines.