Notified Body BSi Group to lead workshop at Pre-filled Syringes

SMi Group are delighted to announce that BSi Group will lead a post-conference workshop on September 16th at the inaugural conference in San Francisco.

In 2020, BSI became the first to issue a Notified Body Opinion to a manufacturer under Article 117 of the Medical Devices Regulation. Introduced by the European Commission under the new MDR, Article 117 requires manufacturers placing drug-device combination products onto the market as an integral device and marketing them as a “medicinal product” to seek Notified Body Opinion. The notified body then confirms the device is compliant with the relevant General Safety and Performance Requirements and provides an opinion to the Medicines Competent Authority to confirm compliance.

BSI has formed a dedicated Medicinal and Biologics Team to provide guidance on Article 117 and focus our full attention on this challenging area of new EU regulation. This workshop will highlight key considerations, potential challenges and provide guidance in navigating Article 117 for the medical devices and combination product industry

Workshop on: A notified body roadmap to Article 117 and pre-filled syringes regulatory strategy

Benefits of attending:
– Review the scope and takeaways of Article 117
– Understand key considerations for developing a regulatory strategy for pre-filled syringes and
combination products
– Prepare for new combination products

The main conference and workshop agenda is available to download from the event website at: www.prefilled-sanfrancisco.com/pharmapr3

Who should attend:

  • Drug-delivery developers
  • Medical Device Engineers
  • Primary Packaging material designers
  • Secondary packagers
  • Smart device developers
  • Training device developers
  • Device-safety solution providers
  • Drug developers

For those interested in attending the main conference, an early bird saving of $300 for bookings made by 29th May is available online.

Proudly sponsored by: Credence MedSystems | Mitsubishi Gas Chemical | PHC Corporation | Plastic Ingenuity | Steris | Steri-Tek | Sumitomo | Zeon Speciality Materials|

For media queries please contact Jinna Sidhu at hsidhu@smi-online.co.uk or call +44 (0)20 7827 6088.

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About SMi Group:

Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk