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SMi is proud to announce the inaugural Prefilled Syringes San Francisco Virtual Conference taking place in September 2020.

The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human factors studies and innovative design and delivery systems within the prefilled syringes industry. 

As part of SMi's leading Injectable conference series, we will assess digital health and connected devices, biologics, biosimilars and biocompatibility for drug/device combination products, platform and device selection, regulatory insights and hear from the West Coast's biotech innovators. 


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,


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

Previous attendees include:

3P Innovation Ltd; Alexion Pharmaceuticals; American Regent Inc; Amgen; Amgen Incorporated; Aptar Pharma; AstraZeneca; BCM Group LLC; BD / Becton, Dickinson and Company; Biogeneral Incorporated; BMS; Bristol Myers Squibb; Bristol-Meyers Squibb; Bristol-Myers Squibb; Celanese Corporation ; Celgene; Connecticut Spring & Stamping; Credence MedSystems, Inc.; Elektrofi; Eli Lilly and Company; Emd Serono; FDA; Ferring Pharmaceuticals; Flexion Therapeutics; Gerresheimer; Grifols; GSK; GSK Pharma; Harro Hofliger Verpackungsmaschinen GmbH; Imbrium Therapeutics; Janssen; Janssen Pharmaceutical Incorporated; Janssen Supply Chain, Johnson & Johnson; kaleo, Inc.; Key Tech; Kiniksa Pharmaceuticals; Lonstruff AG; MedImmune; Merck; Mitsubishi Gas Chemical Company, Inc; Mitsubishi Gas Chemical Singapore Pte Ltd; Momenta Pharmaceuticals; Nipro PharmaPackaging; NN Life Sciences; Nypro; Owen Mumford; Pfizer; Pfizer Inc; Pfizer Inc.; Pharmacircle; PHC Corporation of North America; Plastic Ingenuity Inc; Polyplastics, USA; Purdue Pharma; Regeneron Pharmaceuticals; RheoSense, Inc; Sagentia Ltd; Sanofi; Sanofi Pasteur; Sanofi Pharmaceuticals; Sanofi US; Schott AG; SCHOTT AG - Pharmaceutical; Smithers Rapra; Steri-Tek; Sumitomo Rubber; Takeda; Takeda Pharma Ceuticals International; Terumo Solutions; Teva Pharmaceuticals; Topas Advanced Polymers; Uhlmann; W.L. Gore & Associates, Inc.; West Pharmaceutical Services; zebrasci inc; Zeon Specialty Materials ; Zeon Specialty Materials Inc;


Workshop LEADER


Theresa Jeary

Technical Specialist & Scheme Manager, BSI

Theresa Jeary has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle. She holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person.

Additionally, Theresa has over 12 years Notified Body experience, at BSI as a technical expert and LRQA as the Head of Notified Body. Before re-joining BSI as a technical specialist in the Medicinal and Biologics team, Theresa worked as a consultant to the Medtech sector.


BSI is the business improvement company that enables organizations to turn standards of best practice into habits of excellence. For over a century, BSI has championed what good looks like and driven best practice in organizations around the world. Working with 84,000 clients across 193 countries, it is a truly international business with skills and experience across a number of sectors including healthcare. Through its expertise in Standards Development and Knowledge Solutions, Assurance, Regulatory Services and Consulting Services, BSI improves business performance to help clients grow sustainably, manage risk and ultimately be more resilient and trusted.
To learn more, please visit: www.bsigroup.com/healthcare

Workshop programme

9:00 Opening Remarks and Introductions

Theresa Jeary

Theresa Jeary, Technical Specialist & Scheme Manager, BSI
View Bio

9:10 Understanding Article 117 and key takeaways

Theresa Jeary

Theresa Jeary, Technical Specialist & Scheme Manager, BSI
View Bio

9:50 Considerations for developing a regulatory strategy

Theresa Jeary

Theresa Jeary, Technical Specialist & Scheme Manager, BSI
View Bio

10:30 Morning Break

11:00 An interactive look at a case study

Theresa Jeary

Theresa Jeary, Technical Specialist & Scheme Manager, BSI
View Bio

11:40 Open discussion of case study fi ndings and how

Theresa Jeary

Theresa Jeary, Technical Specialist & Scheme Manager, BSI
View Bio

12:20 Closing Remarks

Theresa Jeary

Theresa Jeary, Technical Specialist & Scheme Manager, BSI
View Bio

12:30 End of Workshop



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CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.


There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.


Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.


Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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