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With FDA’s guidance document Postmarketing Safety Reporting for Combination Products (PMSR) recently finalized, it is imperative for companies to be aware of relevant requirements and how this will need to be implemented for combination products in industry. This workshop will allow for an in-depth assessment of the finalized guidance, introducing key updates and FDA perspectives. An interactive analysis of two case studies will allow delegates to evaluate challenges in implementation and discuss solutions and suggestions from a leading industry expert.

 

  • Understand key updates and new requirements of FDA’s Postmarketing Safety Reporting guidance for Combination Products
  • Engage in regulatory and industry recommendations for effective implementation
  • Assess the new guidance through two interactive case studies
  • Discuss challenges, potential solutions and the global impact

Executives, Directors, VPs, Heads, Principals, Managers of:

  • Pre-Filled Syringes/ PFS
  • Autoinjectors
  • Device/ Device Engineering
  • Human Factor
  • Container Closure Integrity
  • Scientist
  • CMC
  • Product
  • Injectables
  • Sterile Manufacturing
  • Packaging
  • Regulatory Affairs

or anyone who works with Pre-Filled Syringes/ Autoinjectors within pharmaceutical, biotech and solution providers.

Abbott Laboratories; AbbVie; Advanced Molding Technologies; Aegerion Pharmaceuticals; Ajinomoto Althea, Inc.; Allergan; Allergen Inc; Almac Group; Amgen; Antares Pharma; Aptar Pharma; Baxter Healthcare; BCM Group LLC; BioMarin; Boehringer Ingelheim; Connecticut Spring & Stamping; Credence MedSystems; Execution Metrics, Inc; Ferring Pharmaceuticals; Fresenius-Kabi; Genentech; Genentech, Inc.; Gilead Sciences; Glenmark Pharmaceuticals; Harro Höfliger; Inovio Pharmaceuticals; iO Lifesciences; Ionis Pharmaceuticals, Inc.; Matchstick; MedImmune; MedImmune Inc; MedImmune LLC; Medizap; Medtronic; Merck & Co.; Mitsubishi Gas Chemical America Inc; MITSUBISHI GAS CHEMICAL COMPANY, INC; Nemera; Nipro PharmaPackaging; NOVO Engineering, Inc.; Novo Nordisk; Novo Nordisk A/S; One World DMG; Owen Mumford; Pfenex; Pfenex Inc; Pfizer CentreOne; RAUMEDIC INC; Regeneron; Regeneron Pharmaceuticals; Regeneron Pharmaceuticals, Inc.; Shire; Smithers Rapra; Steri-Tek; Stevanato Group S.p.A; Subcuject ApS; Suttons Creek Inc; Terumo Corporation; Terumo Medical Corporation; Terumo Pharmaceutical Solutions; UserWise, Inc.; W. L. Gore & Associates, Inc.; West Pharmaceutical Services,; West Pharmaceutical Services, Inc.; West Pharmaceuticals Services Inc; Worrell; Xeris Pharmaceuticals; ZebraSCI; zebrasci inc; ZEON; ZEON CORPORATION; Zeon Specialty Materials Inc;
 

Workshop LEADER

keynote-img

Khaudeja Bano

Senior. Medical Director, Abbott Diagnostics

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

She is an Abbott President’s award winner, avid Toastmaster and Coach. 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).

Workshop programme

13:00 Registration & Coffee

13:30 Opening Remarks

Khaudeja Bano

Khaudeja Bano, Senior. Medical Director, Abbott Diagnostics
View Bio

13:40 Introductory session

Khaudeja Bano

Khaudeja Bano, Senior. Medical Director, Abbott Diagnostics
View Bio

  • What is the latest news on postmarket safety reporting?
  • An update on FDA’s recent perspective
  • Understanding the finalized FDA guidance
     
  • 14:20 Case Study introduction and preliminary discussion

    Khaudeja Bano

    Khaudeja Bano, Senior. Medical Director, Abbott Diagnostics
    View Bio

  • Delegates will be presented with two case studies which will be used to explore concepts from the final guidance
  • Case Study 1: an example of a device primary mode of action combination product
  • Case Study 2: an example of a drug/biologic
     
  • 15:00 Afternoon Tea

    15:30 An interactive look at the two case studies

    Khaudeja Bano

    Khaudeja Bano, Senior. Medical Director, Abbott Diagnostics
    View Bio

  • Delegates will be split into two groups, each focusing on one of the case studies
  • The groups will review best approaches for effective implementation, assess the applicable requirements and identify challenges and variations of different reports that need to be filled
  • The groups will present and review their findings for both case studies
     
  • 16:30 Open Q&A

    Khaudeja Bano

    Khaudeja Bano, Senior. Medical Director, Abbott Diagnostics
    View Bio

  • Delegates will have the chance to discuss and benchmark concepts and challenges of postmarket safety reporting and the surrounding global issues
  • 16:50 Closing Remarks

    Khaudeja Bano

    Khaudeja Bano, Senior. Medical Director, Abbott Diagnostics
    View Bio

    17:00 End of Workshop

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    VENUE

    Hyatt Regency Mission Bay

    1441 Quivira Road, San Diego, California, USA

    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

    An unparalleled choice for discerning travelers, you’ll find everything you could wish for at our premier Mission Bay hotel near famous San Diego,CA attractions such as SeaWorld San Diego.

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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    Hyatt Regency Mission Bay

    1441 Quivira Road
    San Diego 92109
    USA

    Hyatt Regency Mission Bay

    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

    An unparalleled choice for discerning travelers, you’ll find everything you could wish for at our premier Mission Bay hotel near famous San Diego,CA attractions such as SeaWorld San Diego.

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    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.

    CPD AND PROFESSIONAL INSTITUTES

    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.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    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.

    GLOBAL CPD

    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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