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7th Annual Pre-Filled Syringes & Injectables Summit

  • 27th – 28th October 2021
  • ONLINE flag ONLINE

Vonlanthen Group of Companies is thrilled to be presenting the 7th Annual Pre-Filled Syringes & Injectables Summit, this time as an online event. Join our expert speakers from the comfort of your own home.

This long-running event has been designed for industry leaders to disclose new horizons and developments in pre-filled syringes (PFS) and injectable devices. Attending this event will provide a broad overview of current and upcoming EU MDR regulatory requirements, innovative technologies, the impact of digitalisation, market trends, and device needs. We will discuss the benefits of PFS and injection devices as the main factor for dosage accuracy, convenience, and safe treatment for patients.

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About the 7th Annual Pre-Filled Syringes & Injectables Summit

#VLPFS

Patients are the demand setters for the much safer and easier to use pre-filled drug delivery devices. This high demand is paired with the need of the drug industry to improve material science and formulation technology in order to increase efficiency and allow the shift from freeze-dried vials to pre-filled syringes and pre-filled cartridges packages that reduce costs of manufacturing and packaging.

During the 2-day networking experience, we will discuss the demand for efficient and convenient-to-use drug delivery devices that are used to improve patients’ experience and the key factors for the market growth advancing the technology.  

Get acquainted and network with industry leaders to disclose new horizons and developments in pre-filled syringes (PFS) and injectable devices. The 7th Annual Pre-Filled Syringes & Injectables Summit will help you answer the most pressing industry challenges.  

After the summit, you will receive a digital certificate of attendance to highlight the expertise you’ve gained from the event.

  • KHAUDEJA BANO MD.
  • FATIMA BENNAI-SANFOURCHE
  • ILANIT GOLDGRABER
  • WENDY D WOODLEY
  • CRYSTAL D’SILVA
  • MIN WEI
  • JEAN-SEBASTIEN STEFFEN
  • Yasemin Karanis

Who Should Attend

SVPs, VPs, CEOs, Directors, Department Heads, Leaders, Senior Managers, Principal Scientists, Chemists and Engineers specialising in:

  • Bioprocess Research & Development
  • Business Development
  • CMC
  • Combination Products
  • Container Development
  • Controls & Robotics
  • Device Development & Manufacturing
  • Device Engineering & Design
  • Drug Delivery & Devices
  • Drug Development
  • Drug Packaging
  • External Supply
  • Extractables & Leachables
  • Fill/Finish
  • Formulation Sciences
  • Human Factors Injectables
  • Materials Development
  • Medical & Connected Devices
  • Parenterals
  • PFS
  • A/QC
  • Regulatory Affairs
  • Research & Development
  • Risk Management
  • Smart Devices
  • Stability
  • Standardisation Science
  • Sterile Products
  • Vaccines
  • Validation

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

KEY PRACTICAL LEARNING POINTS

  • A case for change in the world of safety for combination products
  • Life-cycle management of combination products
  • Container closure system qualification and CCIT for PFS-based combination products
  • Interrogating large volume subcutaneous injection delivery systems using translational preclinical and clinical models
  • Impact of the EU MDR on the risk management process for drug-device combination products
  • Combination products and design requirements
  • Importance of dosing flexibility for combination product development

Khaudeja Bano MD., USA

Executive Medical Director, Head of Combination and Device Product Safety

Amgen

Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator, and a certified Project Management Professional.

Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical/clinical and safety leadership roles in devices, diagnostics, pharmaceuticals, and combination products.

She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).

DR. FATIMA BENNAI-SANFOURCHE, DE

Senior Director of QA & RA Compliance for Medical Devices, Combinations Products, and eHealth

Bayer AG

Dr. Fatima Bennai-Sanfourche is working currently as Senior Director of QA & RA Compliance for Medical Devices, Combinations Products, and eHealth at Bayer AG.

Previously she worked in the medical affairs and pharmacovigilance department at Bayer as director of medical device safety global pharmacovigilance/medical device safety officer.

She has more than 15 years of experience in the quality management and regulatory affairs of medical devices field, and over 20 years of supervisory and leadership experience including hiring, training, and performance evaluation.

She studied biology with a focus on biochemistry, immunology, and pharmacology, and did her PhD in pharmacology and pharmacochemistry in Strasbourg, France. She started her professional life with more university-oriented areas doing research and development in France, Sweden, and Germany with a focus on cerebrovascular diseases, such as stroke, regulation of hypertension, and development of immunoassays.

In her current position at Bayer AG, her focus is ensuring the regulatory compliance as well as high product quality of medical device, combination products, and eHealth components of the pharmaceuticals portfolio.

She is also responsible for ensuring compliant use of medical devices and medical software tools in the context of clinical investigations and clinical trials, including accordance with medical device good clinical practice (GCP). She is also leading the project of the implementation of EU MDR for PH-Bayer AG.

She was nominated in 2019 by the European Commission as EFPIA observer for the post-market surveillance and vigilance subgroup (GROW.D4) responsible for the implementation of these process according to the medical device regulation. The period of nomination is of five years starting on March 1, 2019.

WENDY D WOODLEY, US

Staff Scientist II/Translational & Clinical Sciences COE

BD Technologies

Wendy Woodley is a Staff Scientist II for the Translational and Clinical Sciences Center of Excellence at BD Technologies and Innovation (BDTI). She is a published author and inventor with 21 years of R&D and product development experience in the medical device industry with a focus on innovation in drug delivery devices and diagnostics. She received multiple degrees (BS microbiology, BS zoology, BA English, BA history) from North Carolina State University. Her current work at BDTI focuses on drug delivery innovations with a concentration in preclinical model development, clinical testing, and translation of new ideas to product development.

CRYSTAL D’SILVA, BE

Biocompatibility Subject Matter Expert

Baxter International

Crystal D’Silva is a biocompatibility subject matter expert at Baxter International and based in Brussels, Belgium. Currently, she acts as preclinical lead for Baxter’s acute renal and nutrition product portfolios where she engages with a cross-functional team of internal and external stakeholders to conduct biological risk evaluations according to global guidelines. Additionally, she co-chairs an internal task force with a focus on hemocompatibility, in vitro toxicology, and the dissemination of lessons learned from regulatory submissions.

She is actively involved in standard development as a member of the ISO/TC 194 biological and clinical evaluation of medical devices technical committee and she is also a member of the European Society of Toxicology In Vitro (ESTIV) and the Belgian Society of Toxicology and Ecotoxicology (BELTOX). She has a PhD in medical biophysics from the University of Toronto in collaboration with the Princess Margaret Cancer Centre and the Hospital for Sick Children (Ontario, Canada), and an MSc in pathology and molecular medicine from Queen’s University (Ontario, Canada).

MIN WEI, US

Senior Director

AstraZeneca

Min is a Senior Director at AstraZeneca and leads the pre-filled syringe technology development for the company’s biologic pipeline. He has over 15 years of pharmaceutical product development experience. Prior to AstraZeneca, Min was the drug product lead at Johnson & Johnson. He has worked on projects from discovery phase through commercialisation. His experience spans formulation development, process engineering, and manufacturing. Currently, Min is focusing on development for new therapeutic technologies, including digital health and cell and gene therapy. Min received his PhD in materials science and his MBA from US. Min is an inventor or author of more than 100 issued patents and patent applications and peer-reviewed publications.

JEAN-SEBASTIEN STEFFEN, CH

Group Lead Combination Product and Primary Packaging

Lonza AG

Jean-Sébastien Steffen leads the combination product and primary packaging development organization with Lonza Drug Product Services (Basel, Switzerland).  He supports Lonza’s customers with 14 years of experience in medical devices and combination products development. He notably contributed to the success of 18 marketed drug-devices combination products.

Jean-Sébastien has also been a key player in establishing global pre-filled syringe technology platforms for different large pharmaceutical companies and has developed extensive expertise regarding container closure integrity, drug-container interaction, and combination product functionality. As a certified lean six-sigma black belt since 2016, he particularly enjoys implementing innovative scientific discoveries in efficiently running processes.

Jean-Sébastien holds a PhD in health engineering from Arts et Metiers ParisTech (France) and a master’s degree in mechanical engineeering from Karlsruhe Institute of Technology (Germany).

 

Khaudeja Bano MD., USA

Executive Medical Director, Head of Combination and Device Product Safety

Amgen

DR. FATIMA BENNAI-SANFOURCHE, DE

Senior Director of QA & RA Compliance for Medical Devices, Combinations Products, and eHealth

Bayer AG

WENDY D WOODLEY, US

Staff Scientist II/Translational & Clinical Sciences COE

BD Technologies

CRYSTAL D’SILVA, BE

Biocompatibility Subject Matter Expert

Baxter International

MIN WEI, US

Senior Director

AstraZeneca

JEAN-SEBASTIEN STEFFEN, CH

Group Lead Combination Product and Primary Packaging

Lonza AG

BROCHURE

Request the 7th Annual Pre-Filled Syringes & Injectables Summit brochure and find out the latest topics and ideas that will be shared.

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