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SMi Group are delighted to announce the 10th annual Biosimilars conference taking place on 25th and 26th of September 2019 in London, UK. SMi will be collating our audience and holding our first international conference in London.

The biosimilars market is forecasted to reach USD$23.6B by 2023 at a compound annual growth rate (CAGR) of 31.70%. Factors driving the increase of this market include growing demand for biosimilar drugs due to their cost-effectiveness, growing incidence of chronic diseases, and strategic collaborations resulting in enhanced productivity and clinical trial activities.

With the expiry dates of major patents fast approaching, the emerging gap in the market for biosimilars is now a major attraction for  manufacturers. As the availability of biosimilars could potentially reduce direct spending by USD$54B by 2026, the question is what can current biosimilar producing companies do to join this market to benefit the patients, physicians and investors?


 

HEAR  about  the current updates in patent laws provided by legal experts

DISCUSS the strategies being implemented to enhance the medical communication between stakeholders, physicians and patients

EXPLORE the landscape of  biosimilar commercialization in various international markets

REVIEW the recently  approved drug delivery  systems for biosimilars

Previous attendees included:

Presidents, Vice Presidents, Managing Directors, Directors, Associate Directors, Chiefs, Heads, Principals, Managers and Analysts of:

Biosimilar Development
Product Development
Commercialization
Market Access
Medical Affairs
Intellectual Property
Bioloigcs
Biopharmaceuticals
Research and Development
Generics
Biobetters
Business Development
Strategic Marketing
Drug Development
Clinical Trials
Immunogenecity Studies

Global Presence:

Attendees from all over the world attend our events. Gain hands on insight from representatives from UK, Europe and USA.

 

Alliance For Safe Biologic Medicines; Barclays; Bioceros; Biocon; Bionovis; Boehringer Ingelheim International; Boehringer Ingelheim Pharma GmbH & Co. KG; Bristows LLC; Celltrion; Celltrion Inc.; Challand Biosimilar Consulting; CinnaGen Inc; CIRION; EXANE BNP Paribas; Faculty of medicine of Mauritania; Farmacia; GaBI Journal ; Gan & Lee Pharmaceuticals; Gan & Lee Pharmaceuticals USA Co.; Gedeon Richter Ltd; Gedeon Richter Plc.; Generics Bulletin; GfK HealthCare; HealthTrust Europe LLP; Independant Consultant; Iqvia; Lupin (Europe) Ltd; medac GmbH; Mishcon de Reya LLP; Norwegian Medicines Agency; Prolong Pharmaceuticals; SAI MedPartners; Samsung Bioepis; Sun Pharmaceutical Industries; Teva Pharma BV; University Of Central Lancashire; University Of Portsmouth; Utrecht University.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Michel  Mikhail

Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars, Chairperson
View Bio

9:10 Commercialising Biosimilars - mastery or mystery?

Dan Cohen

Dan Cohen, Regional Senior Director, Biosimilars UK, Ireland and Netherlands, Biogen Idec Limited
View Bio

  • Variation in needs and market dynamics of biosimilar uptake across Europe
  • Biogen’s navigation within this with a focus 3 different European markets: UK, Ireland & Netherlands
  • Successes and challenges Biogen have faced to date
  • What’s next – how to engage and accelerate biosimilar progress
  • 9:50 Past, Present & Future outlook for Biosimilars

    Aurelio Arias

    Aurelio Arias, Senior Consultant, Thought Leadership, IQVIA
    View Bio

    • Drivers for global uptake and free market dynamics
    • Patients first: Successful defense strategies
    • Maintaining a sustainable biosimilars market
     

    10:30 Morning Coffee

    11:00 Using SPOT™ and SLIM™ technology and upstream process modulation to reduce cost of goods of biosimilars.

    Louis Boon

    Louis Boon, CSO Bioceros BV, Bioceros BV
    View Bio

    • Increase specific productivity using SPOT™
    • Increase specific productivity and biosimilar product quality using upstream process modulation
    • Reduce process issues using SLIM™
    • Reducing cost of goods of biosimilars

     

    11:40 Australia and the flow in payer-driven distribution

    Stephen Murby

    Stephen Murby, Board Member, Alliance for Safe Biologic Medicines (ASBM)
    View Bio

    • Just as biologics are not chemicals so there is a need for new business models for biosimilars.
    • Substitution of biosimilars is not the same as supervised clinical switching
    • Biosimilar pharmas & payers underestimate Patients, Prescribers and Pharmacists at their risk
    • The key to access is confidence not cost


     

    12:20 Networking Lunch

    13:20 Indication of the MHRA's decision making regarding biosimilar approval

    Anne Cook

    Anne Cook, Biologicals Quality Assessor, MHRA
    View Bio

    • Insight into new assessment procedures being offered, including the involvement of the EMA (European Medicines Agency)
    • Targeted assessment of new active substances or biosimilars with EMA positive opinion (in case of no deal)
    • Possible rolling review of new active substances and biosimilar products by MHRA
    • Exploring the future obstacles that will prevent approved biosimilars from reaching the market
     

    14:00 Barriers behind the development and uptake of biosimilars in the US

    Rodeina Challand

    Rodeina Challand, Executive Director, Project Management, Worldwide Clinical Trials, Challand Biosimilar Consulting
    View Bio

    • Understanding why the US’s regulatory machinery has caught up with the approval of several biosimilars, yet only a few have been launched?
    • Evaluation of the impact this predicament has in terms of starving the public from access to affordable healthcare
    • American features of the biosimilar market include late development of guidelines, patient litigations, interchangeability regulation and lack of systematic effort in educating physicians and patients.
    • What are policy makers doing to encourage uptake?
     

    14:40 Afternoon Tea

    15:10 Exploring the environment for biosimilars in China

    Bert  E. Thomas IV

    Bert E. Thomas IV, Senior Vice President, Business Development, Bio-Thera Solutions, Ltd
    View Bio

    • Discussing the recent changes in the regulatory policies of biosimilars
    • Overview on the evolution of biosimilars development in China
    • Understanding the impact of the regulatory changes and how they affect biosimilars development
    • Updates on biosimilars market in China and China biosimilars developers
     

    15:50 Business Development and Portfolio strategy

    16:30 Chairman's Closing Remarks and Close of Day One

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars, Chairperson
    View Bio

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars, Chairperson
    View Bio

    9:10 How to make biosimilars a future reliable source?

    Steinar Madsen

    Steinar Madsen, Medical Director, Norwegian Medicines Agency
    View Bio

    • Addressing the importance of patients’ interest
    • Impact of loss of  biosimilar market on pricing
    • Commercial advantages of rise in biosimilar market to originator companies
    • Discounting of biosimilars – benefits and drawbacks
     

    9:50 Panel Discussion: Concerns with the possible changes in regulations of biosimilars in the UK post Brexit

    • Debating how Brexit would impact the launch of forthcoming biosimilar drugs in the UK market
    • Major setback of approval – possible need of 2nd approval from MHRA
    • Risks of some biosimilar manufacturing companies skipping the UK all together due to extensive costs
    • Hindering of the cost cutting approach of the NHS
     

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars, Chairperson
    View Bio

    Liz Pollitt

    Liz Pollitt, Director, BioPharma CMC Regulatory Consultancy Services Ltd
    View Bio

    Anne Cook

    Anne Cook, Biologicals Quality Assessor, MHRA
    View Bio

    10:30 Morning Coffee

    11:00 Current updates in patent protection costs – how will this impact the biosimilars market.

    Gregory Bacon

    Gregory Bacon, Partner, Bristows LLP
    View Bio

    • A review of  biosimilars litigation date
    • Introduction of Arrow Declarations – newly developed mechanism overriding the secondary patents currently protecting key originator biologic products.
    • Case study on Humira: first drug to be granted arrow declaration
    • Settlement Agreements – is it safe to go back into water?
     

    11:40 Drug Delivery Systems for Biosimilars – Copy or Innovate

    Sebastian Maag

    Sebastian Maag, Device Project Leader, Novartis – Sandoz GmbH
    View Bio

    • Regulatory requirements and opportunities to differentiate
    • Formulation and Container Closure System – case studies with challenging proteins
    • Injection Devices – understanding, predicting and aligning different customer needs for a truly competitive product design
     

    12:20 Networking Lunch

    13:20 Biosimilars: Reframing communications and changing behaviours

    Christian  Agboton

    Christian Agboton, Senior Global Brand Medical Director, Takeda Pharmaceuticals International GmbH
    View Bio

     • Overview of the progress of Infliximab biosimilars following their launch
    • Role of Medical Affairs and Medical Communications
    • What’s next? biosimilars as an incentive for innovation
     

    14:00 Assuring the Quality of Biosimilars through International Standards

  • Focus on maintaining the quality of biosimilars following its authorization
  • The role of WHO standards of biological activity in maintaining potency
  • Current Developments in International Standards
  • Meenu Wadhwa

    Meenu Wadhwa, Section Leader, Cytokines and Growth Factors, Biotherapeutics Group , NIBSC, MHRA

    14:40 Afternoon Tea

    15:10 Patent protection – the international perspective

    Christopher Stothers

    Christopher Stothers, Partner, Freshfields Bruckhaus Deringer LLP
    View Bio

    • Multi-dimensional chess - multiple patents, multiple owners, multiple countries
    • Resolution and settlement of biosimilars patent litigation to date
    • A new system – the UPC or ADR?
     

    15:50 Case study: The first monoclonal antibody manufactured with a fully continuous biomanufacturing process that enters phase I studies

    Jaap Wieling

    Jaap Wieling, Chief Development Officer, BiosanaPharma BV
    View Bio

    • Insight into the development of BiosanaPharma’s biosimilar Omalizumab
    • Explaining the cost-saving advantages of this innovative manufacturing process
    • Overview of the non-clinical studies prior to phase 1 clinical trial approval without any animal studies
     

     


     

    16:30 Chairman’s Closing Remarks and Close of Day Two

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, Global Expert in Biosimilars, Chairperson
    View Bio

    +

    FEATURED SPEAKERS

    Anne Cook

    Anne Cook

    Biologicals Quality Assessor, MHRA
    Aurelio Arias

    Aurelio Arias

    Senior Consultant, Thought Leadership, IQVIA
    Christian  Agboton

    Christian Agboton

    Senior Global Brand Medical Director, Takeda Pharmaceuticals International GmbH
    Dan Cohen

    Dan Cohen

    Regional Senior Director, Biosimilars UK, Ireland and Netherlands, Biogen Idec Limited
    Michel  Mikhail

    Michel Mikhail

    International Expert in Regulatory Affairs, Global Expert in Biosimilars, Chairperson
    Stephen Murby

    Stephen Murby

    Board Member, Alliance for Safe Biologic Medicines (ASBM)

    Anne Cook

    Biologicals Quality Assessor, MHRA
    Anne Cook

    Anne Cook is an Expert Quality Assessor in the Biologicals Unit at MHRA (UK), where she has worked for 14 years. She has assessed new Marketing Authorisation Applications for several biotechnology products, from enzyme replacement therapies to biosimilar products, including monoclonal antibodies. She also provides scientific advice to companies and academic groups who are developing biological products. Anne was an active member of the Biosimilar Guideline revision (Quality) working party at the European Medicines Agency (revised guideline published in 2014, EMA/CHMP/BWP/247713/2012). She is a member of the National Biosimilar Medicines Programme Board, chaired by the Chief Pharmaceutical Officer, NHS England.
     

    Aurelio Arias

    Senior Consultant, Thought Leadership, IQVIA
    Aurelio Arias

    Aurelio is a Senior Consultant in the European Thought Leadership team based in IQVIA’s London office. The Thought Leadership group creates topical and forward-looking content relevant to pharma executives worldwide. Aurelio’s predominant focus is on off-patent markets where he generates evidence-led insights with a view to spark high-level discourse in established brands, biosimilars, generics and value-added medicines. He is considered a subject matter expert in these areas where he speaks at numerous conferences worldwide, presents to clients and engages in consulting projects in an advisory capacity. Prior to IQVIA, Aurelio has worked as a strategy consultant in Life Sciences for LEK and Accenture, and in R&D for Pfizer and GlaxoSmithKline.
     

    Bert E. Thomas IV

    Senior Vice President, Business Development, Bio-Thera Solutions, Ltd
    Bert  E. Thomas IV

    Bert is currently Senior Vice President, Business Development of Bio-Thera Solutions, a China-based pharmaceutical company. Prior to joining Bio-Thera, Bert was Chief Executive Officer of the Sarcoma Foundation of America (SFA), an organization focused on funding sarcoma research. Before joining SFA, Bert held multiple leadership positions at the American Association of Cancer Research (AACR). Prior to the AACR, Bert held positions in R&D and Business Development with Genetics Institute, Wyeth, Guilford Pharmaceuticals, MGI Pharma, Procept and Adolor Corporation. Bert holds a PhD from UCLA, an MBA from Johns Hopkins University and is a graduate of Butler University.

    Christian Agboton

    Senior Global Brand Medical Director, Takeda Pharmaceuticals International GmbH
    Christian  Agboton

    Christian J. Agboton currently serves as Senior Global Brand Medical Director at Takeda Pharmaceuticals, in Zurich, Switzerland. He contributed to launch the first infliximab biosimilar in Europe as Medical Director Autoimmune diseases at Hospira/Pfizer.  He also worked on etanercept and adalimumab biosimilars at Sandoz biopharmaceuticals. What Medical Affairs can bring to the field and how this role might evolve in the next future will be at the centre of his talk. Christian is member of the faculty of pharmaceutical medicine of the Royal College of Physicians of the UK.
     

    Christopher Stothers

    Partner, Freshfields Bruckhaus Deringer LLP
    Christopher Stothers

    Christopher is an experienced litigator on strategic, cross-border patent disputes, including opposition work before the European Patent Office. He works in all fields of technology, from pharmaceuticals, biotechnology and medical devices to software and telecommunications.
    Christopher also litigates and arbitrates other types of intellectual property, antitrust and pharmaceutical regulatory issues. He is a creative problem-solver who thinks laterally across the breadth of his practice. Christopher is a Visiting Professor in Intellectual Property and Competition Law at University College London and published the leading textbook “Parallel Trade in Europe: Intellectual Property. Competition and Regulatory Law”. He is committed to pro bono matters, in particular those raising issues of (trans) gender and disability rights.
     

    Dan Cohen

    Regional Senior Director, Biosimilars UK, Ireland and Netherlands, Biogen Idec Limited
    Dan Cohen

    Dan is a Regional Senior Director at Biogen, responsible for commercialisation of their anti-TNF portfolio across UK, Ireland & Netherlands. Dan has over 20 years’ experience in the pharma/biotech industry, ranging across multiple leadership and specialist roles, including both launch and life cycle management, in both originator and biosimilar markets. Dan sits as a board member of the BBA, and most recently Dan has led a highly successful Imraldi (adalimumab) launch at Biogen. The focus of the talk will include the core strategic focus areas for biosimilar uptake, and a longer-term view on the criticality of a sustainable market.

    Gregory Bacon

    Partner, Bristows LLP
    Gregory Bacon

    Greg Bacon is an experienced IP lawyer with a particular focus on the life sciences sector. He has advised and represented clients on small molecule pharmaceuticals, biologics (originators and biosimilars), medical devices (traditional and software), as well as in the chemicals, technology, shipping and online publishing sectors.
    Greg’s particular focus is on patent litigation. He has extensive experience of acting before both the English High Court and Court of Appeal. In addition, he regularly advises on and coordinates strategic multinational litigation projects for biopharma clients. He also provides regulatory advice on the legislative frameworks governing pharmaceuticals and medical devices, both at EU and national level.
     

    Jaap Wieling

    Chief Development Officer, BiosanaPharma BV
    Jaap Wieling

    Dr. Jaap Wieling brings over 25 years of experience as an executive and entrepreneur in pharmaceutical research and development. He is a seasoned expert in building effective and efficient R&D organizations. His comprehensive and commonsensical approach ensures the best possible way to efficacious development of candidate medicines. Jaap fulfills executive, board and advisor positions in startup biotech companies and (pharmaceutical) service industries since 1999. Before that he held executive and research management roles in R&D institutions and commercial research and manufacturing corporations. Jaap has been a University teacher throughout his career and he serves as an expert volunteer for non-profit organizations. His current main activities are CSO at BiosanaPharma bv in the Netherlands, and CEO of BiOraliX, Biosana’s formulation development company. Jaap lives with his family in a scenic part of the province of Friesland, The Netherlands.
     

    Liz Pollitt

    Director, BioPharma CMC Regulatory Consultancy Services Ltd
    Liz Pollitt

    Liz Pollitt is an independent consultant at BPCRCS, providing strategic and technical advice to clients on regulatory aspects of CMC for biological and biosimilar products. Formerly a senior pharmaceutical assessor in the Biologicals Unit at the MHRA involved in the assessment of all types of biological products, her focus on biosimilar products began as VP of CMC for Regulatory Affairs at CELLTRION, and she subsequently worked in the Biosimilars unit at Merck KGaA. Liz holds a PhD in Viral Immunology from the University of Leicester and completed postdoctoral studies at the Institute of Virology, University of Glasgow.

    Louis Boon

    CSO Bioceros BV, Bioceros BV
    Louis Boon

    Dr. Boon received his Ph.D. in Biochemistry at the University of Amsterdam. In 2003 he was one of the founders of Bioceros BV were he currently hold a position of CSO. In addition, he held position as CSO for 4AZA Bioscience NV, FF Pharma and VP Preclinical for PanGenetics BV and Tanox. Dr. Boon is author of over 280 papers in international scientific journals in the field of medical biotechnology. In his position as CSO of Bioceros he is responsible for the pre-clinical development of novel and biosimilar monoclonal antibodies.

    Meenu Wadhwa

    Section Leader, Cytokines and Growth Factors, Biotherapeutics Group , NIBSC, MHRA
    Meenu Wadhwa

    Michel Mikhail

    International Expert in Regulatory Affairs, Global Expert in Biosimilars, Chairperson
    Michel  Mikhail

    Dr. Michel Mikhail has more than 30 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical Companies, Biotech Companies as well as in the Generics industry. He is a Chartered Expert in Pharmacology-Toxicology, a chartered Clinical Expert as well as a chartered Analytical Expert. Dr. Mikhail is a Global Expert in Biosimilars and International Regulatory Affairs Expert. He served as member of the Expert committee of the Government Federal Institute of Risk Assessment (BfR) Germany and served as member of the Expert Committee for Toxicology of the United States Pharmacopoeia (USP).

    Rodeina Challand

    Executive Director, Project Management, Worldwide Clinical Trials, Challand Biosimilar Consulting
    Rodeina Challand

    Science and Law Graduate with 30 years of experience in healthcare, cancer research, pharmaceutical industry and CRO, across a wide range of roles including developing and implementing clinical development strategies for biosimilars and complex generics. Experience in all aspects of biosimilar development including study design and regulatory agency discussions (EMA, FDA, MENA, GCC, Australia, India, Japan and S. Korea). In the last few years have worked with the developing regions and conducted several meetings with MENA and GCC Regulatory Agencies to educate and better understand their expectations licensing biosimilars; also supporting them in implementing clinical trial regulations and educating potential investigators in the region. Worked on over 15 biosimilar molecules across a range of products and indications, including ESAs, Filgrastims, Heparins, Insulins and monoclonal antibodies in various capacity including consulting, regulatory and clinical strategies, feasibility and supporting study delivery across all phase of development (phase I to IV).

    Sebastian Maag

    Device Project Leader, Novartis – Sandoz GmbH
    Sebastian Maag

    In his role as Device Project Leader at Novartis Sebastian Maag leads and manages cross-functional project teams in the development of device and packaging aspects of Biosimilar projects within the Sandoz portfolio.
    Sebastian has a diploma degree in plastic and rubber technology, is a PMP certified project manager and is currently pursuing a MBA in Medical Devices & Healthcare Management.
    Prior to joining Sandoz he has been working several years in the development and industrialization of medical devices and combination products at Raumedic AG and Maquet AG.
     

    Steinar Madsen

    Medical Director, Norwegian Medicines Agency
    Steinar Madsen

    Dr. Steinar Madsen is medical director at the Norwegian Medicines Agency. He is engaged in the drug information service at the Agency, with a special interest in the safe and cost effective use of drugs. He has been working with generic substitution for almost 20 years and biosimilars for more than 10 years. He is a member and previously chairman of the committee for generic substitution at the Agency. He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology.

    Stephen Murby

    Board Member, Alliance for Safe Biologic Medicines (ASBM)
    Stephen Murby

    Stephen is a member of the International Advisory Board of the Alliance for Safe Biologic Medicines (ASBM), headquartered in Virginia, USA; a Special Board Representative of the Consumer Health Forum of Australia (CHF); and a biosimilars spokesperson for the International Alliance of Patients’ Organizations (IAPO), headquartered in London. In 2014, Stephen was made an Honorary Life Member of CHF. He is also a Life Fellow of the Royal Society of Arts (RSA), headquartered in London and a Life Member of the Graduate Union of the University of Melbourne.

    Stephen has a special interest in biosimilars from the patient perspective and has been working with ASBM, CHF, IAPO and others over the past eight years in developing and disseminating biosimilars information and educational resources to patient, prescriber and dispenser organisations around the world.

    In 2017 he travelled to Australia for top-level meetings with peak professional organisations and government bodies on the outcomes of the ASBM Australian Prescribers Survey. Stephen has spoken at peak body meetings on biosimilars in The Philippines, Hong Kong, Australia, Switzerland, USA and the United Kingdom.
     

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    Workshops

    Interchangeability in the USA: The US-FDA Regulatory Guidance
    Workshop

    Interchangeability in the USA: The US-FDA Regulatory Guidance

    Copthorne Tara Hotel
    24th September 2019
    London, United Kingdom

    Advancing biosimilars development and uptake in MENA and GCC regions
    Workshop

    Advancing biosimilars development and uptake in MENA and GCC regions

    Copthorne Tara Hotel
    24th September 2019
    London, United Kingdom

    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    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.
    HOTEL BOOKING FORM

    2019 Biosimilars Preliminary Attendee List

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    Biosimilars INFOGRAPHIC

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    Speaker Interview with Jaap Wieling

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    Speaker Interview with Aurelio Arias

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    Speaker Interview with Anne Cook

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    SPEAKER INTERVIEW WITH Stephen Murby

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    Speaker Interview with Chair MICHEL MIKHAIL

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    2016-2018 Biosimilars Conference Past Attendees

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    2019 Chair letter invite

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    SPEAKER BIOGPRAHIES

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    Biosimilars Conference 2019 Programme

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    Biosimilars Conference 2019 Workshops

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    Biosimilars Conference 2019 Brochure

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    2016 Biosimilars Conference Presentation by IMS Health

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    2016 Biosimilars Conference Presentation by Biogen

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    2017 Biosimilars Conference Presentation by BRISTOWS

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    2017 Biosimilars Conference Presentation by Global Expert Biosimilars

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    2017 Biosimilars Conference Presentation by Teva Pharmaceuticals

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    2018 Biosimilars Conference Presentation by Boehringer Ingelheim

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    2018 Biosimilars Conference Presentation by SANDOZ

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    Generics and Biosimilars Initiative (GaBI) was founded in 2008. GaBI aims to foster the worldwide efficient use of high quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable and sustainable health care. The objective of GaBI is to raise the scientific status of generic and biosimilar medicines, via well-documented and up-to-date information about generic and biosimilar medicines both in print (www.gabi-journal.net) and electronically (www.gabionline.net) in an open access format, providing high quality, scientifically sound and reliable information to healthcare professionals including physicians, pharmacists and nurses, consumers, drug developers, third-party payers, legislators and assessors; who are in need of a reliable, critical and independent source of information on all aspects of generic and biosimilar medicines. Subscribe to gain easy access of information on the latest scientific research and developments in generic and biosimilar medicines via GaBI Online to editorial@gabionline.net; or submit a manuscript to GaBI Journal to editorial@gabi-journal.net. GaBI’s mission – Building trust in cost-effective treatments


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    About Us Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.


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    BiosimilarNews.com is a leading international knowledge and information source about biosimilars. The site helps the industry professionals, clinicians and also the public to find timely and appropriate information about this specific area. Biosimilar News - We keep you up to date.


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    http://www.biosimilardevelopment.com/

    Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property. Biosimilar Development is part of the Life Science Connect media group, which strives to facilitate connections and foster collaborations in pharmaceutical development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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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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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
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