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In the first part of the workshop we will look at key aspects of EU and US marketing applications that have succeeded and those that have failed looking at relevant endpoints, patient populations and outcome measures.

The second part of the workshop will focus on Market Access opportunities and unmet need for new medicinal products intended for the treatment of pain in Europe and USA.

  • This interactive workshop will introduce participants to a 360° approach to Regulatory challenges and opportunities related to the development of Pain Treatment Products.
  • The workshop will illustrate Clinical Development aspects aimed at the successful design and execution of clinical studies through an analysis of unmet needs, endpoints and outcomes.
  • You will finally be able to gather insights on current treatment practice and Market drivers for future Neuropathic, Chronic and Post-Operative Pain treatment products

Chief Executive Officer, Chief Scientific Officers, Chief Medical Officers, Managing Directors, CEO, Head of Department, Principal Research Scientists, Clinical lead, Clinical Operations in the following fields:

Pain and Migraine
Inflammation
Chronic Pain
Neuropathic Pain
Analgesic pre-clinical development
Anaesthesia and Pain Management
CNS clinical trials
Ion Channel Pharmacology
Pharmacology Intelligence
Translational science
Drug development
Exploratory development

Past Attendees include:

AiCure; Amgen; Analgesia Partnership; Apollo Therapeutics; AstraZeneca; Bayer; Bayer AG; biogen; Cara Therapeutics ; Centre for Human Drug Research; Centrexion Therapeutics Corp.; Chdr; Clermont Universit; Convergence Pharmaceuticals; Daiichi Sankyo Co. Ltd.; Daiichi Sankyo co.ltd; Eli Lilly and Company; ENSCCF Sigma Clermont; Eupraxia Pharmaceuticals Inc; Family Cottage Sydney; GlaxoSmithKline; Grunenthal; Grunenthal GmbH; Gsk; Innopain; Ipsen Innovation; J & JPRD; Kings College London; Lucideon; MD Biosciences; Merck & Co.; MRC Technology; Mundipharma International Limited; Mundipharma International Ltd; Mundipharma Research; Mundipharma Research GmbH & Co. KG; Mundipharma Research Ltd; Nektar Therapeutics; NeuroDigm; Novartis; Pharmaleads; Premier Research; Queens University Belfast; Queen's University Belfast; Transpharmation Ltd; University of Manchester; US Army Institute for Surgical Research; Zoetis

 

Workshop LEADER

keynote-img

Simon Ruini

Director, Pharma Design Ltd.

Simon Ruini is Managing Director of Pharma Design Limited, a boutique service provider for the biotech and pharmaceutical industry. Simon is a well-qualified professional with broad experience in Regulatory, Safety and Clinical Development in the pharma and biotech. He specializes in Marketing Authorisation filings in EU and Clinical Study design. Simon is a visiting lecturer at UNIGE in Geneva and ETH in Zurich. During his consulting career Simon has provided advice and work for Roche-Genentech, Eli Lilly, Sanofi, Novartis, Norgine, Mitsubishi Tanabe, Alliance Unichem.
 

Pharma Design Ltd.

Pharma Design is a small service provider with a network of specialised consultants assisting Pharmaceutical Companies & Biotechs in achieving Marketing Authorisations in Europe and preparing adequately for Market launch. The Company provides assistance with Clinical Study design, Marketing Applications and Drug Safety services (i.e. Pharmacovigilance) during drug development and post-marketing.
 

Workshop programme

13:30 Registration & Coffee

14:00 Opening Remarks and Introductions

Simon Ruini

Simon Ruini, Director, Pharma Design Ltd.
View Bio

14:10 Guidelines and Regulatory Aspects regarding Clinical Development of products intended for the treatment of pain

Simon Ruini

Simon Ruini, Director, Pharma Design Ltd.
View Bio

  • Comparison of guidelines and regulatory aspects in E.U and U.S.A
  • Definitions and indications
  • EMA and FDA Guidance
  • Claims and labelling
  • Limitations of established pain classifications
  • 14:50 Clinical Study design for the development of products intended for the treatment of pain.

    Simon Ruini

    Simon Ruini, Director, Pharma Design Ltd.
    View Bio

  • Clinical endpoints
  • Choise of comparators
  • Patient Populations
  • Outcome measures
  • Unmet needs
  • 15:30 Afternoon Tea

    16:00 Recent License Approvals in E.U. and U.S.A.

    Simon Ruini

    Simon Ruini, Director, Pharma Design Ltd.
    View Bio

  • Recent EMA and FDA License aprovals
  • What has convinced Regulators?
  • Whathas not convinced regulators?
  • 16:40 Inflammatory, Chronic and Post-operative pain treatments - Market opportunities in E.U. and U.S.A.

    Simon Ruini

    Simon Ruini, Director, Pharma Design Ltd.
    View Bio

  • Patient Journeys
  • Mrket objectives
  • Prescribing trends in EU and USA
  • 17:20 Closing Remarks

    17:30 End of Workshop

    +

    VENUE

    Holiday Inn Kensington Forum

    97 Cromwell Road , London, United Kingdom

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

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    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    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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