News

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.

Contact us if you wish to meet with Emmanuelle.

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.

Contact us if you would like to meet with Valerie.

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.

Contact us if you would like to arrange to meet with Richard.

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.

Contact us to arrange for a meeting, or hear about the panel discussion.

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.

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

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.

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.

Contact us if you would like to meet Sylvie and Sabah.

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.

Contact us if you would like to arrange a meeting with our team attending the conference

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.

Contact us if you would like to arrange for a meeting with Richard.

Sabah Malek will present on Strategies for Companion Diagnostics Development at Molecular Med TRI-CON 2013 (San Francisco – February 12, 2013). Sabah will specifically focus on the design of drug clinical trials incorporating a companion diagnostic test.

For more details, feel free to contact us.

VCLS will be chairing a workshop on Innovative Combination Products: challenges and approval (EU, US) at Pharmapack Europe 2013 (Paris, February 14). Anne Dupraz-Poiseau, Sylvie Le Gledic, and Marielle Fournier will discuss the specificities and challenges of combination product development and registration in the EU and the US. The workshop will be illustrated with specific case studies related to innovative drug-device combinations: medicinal products, medical devices and Companion Diagnostics.

Anne Dupraz-Poiseau will also chair the session focused on The Targeted Drug Delivery via Convergent Technologies.

Contact us if you would like to arrange for a meeting with Anne, Sylvie or Marielle.

Sylvie Le Gledic will participate in the Annual European IVD Performance Evaluation and Regulatory Conference (Frankfurt, February 25 & 26). The event will be an opportunity for diagnostic professionals to discuss the highly anticipated draft of the new IVD EU regulation, released by the European Commission last September. New requirements for diagnostic performance evaluation, including companion diagnostics, will be presented and commented. The key points of the new regulation are changes in the role of Notified Bodies, classification rules and related conformity assessment procedures, new requirements for vigilance and post market surveillance, e-labeling policies and procedures for European diagnostics.

For more details, feel free to contact us.