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Discover the latest trends in manufacturing, research and development in outsourcing at SMi’s Outsourcing in the Pharmaceutical Industry Conference. Update yourself and your organisation with the latest regulatory guidelines governing this topical area. The Conference covers new trends such as e-sourcing, integrated outsourcing solutions and security strategies for outsourcing. It will also be supported by case studies from the Indian and Chinese markets.

What are outsourcing partners looking for? How do you identify and select partners? How do you manage the relationship? What are the critical factors affecting success in major outsourcing agreements? And how do you avoid and manage the risk associated with these collaborations? These are the questions that will be discussed and fully covered in this comprehensive networking forum.

Outsourcing in the Pharmaceutical Industry will provide an excellent opportunity to network, enhance your company’s profile and keep up-to-date on the latest issues in the Pharmaceutical Outsourcing market.

Gain an insight from key industry leaders in the field including: 

Elizabeth Moench, President & Chief Executive Officer, MediciGroup 
Dr Edward Leung, Vice President, Preclinical Research & Development, King Pharmaceuticals 
Dr George Partelow, Global Programme Manager, AstraZeneca 
Dr Arvind Mathur, Manager External Resources, Bristol-Myers Squibb 
James Clifford
, Manager, Maintenance Systems, Wyeth 
Todd Hintze, Healthcare Practice Group President, Everest Group

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Todd Hintze

Todd Hintze, Healthcare Practice Group President , The Everest Group

9:10 INTRODUCTION TO THE OUTSOURCING INDUSTRY

Todd Hintze

Todd Hintze, Healthcare Practice Group President , The Everest Group

  • Outsourcing is not a new tool in the healthcare industry
  • Pharmaceutical organisations fail to capture the full value of outsourcing
  • Once cost savings are made, companies find outsourcing complicated and an under unutilised process
  • Too much is at stake for companies to outsource even before they understand fully the value of outsourcing
  • Key methods that successful organisations have used to identify and capture targeted outcomes
  • Case study and examples will be shown on solutions development, supplier evaluation and negotiations and contracting
  • 9:50 OPPORTUNITIES IN INDIAN AND CHINESE PHARMACEUTICAL MARKETS

    Amarpreet Dhiman

    Amarpreet Dhiman, Drug Discovery & Clinical Diagnostics Analyst , Frost & Sullivan

  • Overview of Indian and Chinese pharmaceutical markets
  • Outsourcing opportunities in pharmaceutical manufacturing
  • Clinical trial opportunities
  • Outsourcing opportunities in pharmaceutical research and development
  • 10:30 Morning Coffee

    11:00 BEST PRACTICES IN DRUG DISCOVERY OUTSOURCING

    Arvind Mathur

    Arvind Mathur, Manager, External Resources, Bristol-Myers Squibb PRI

  • Realities of outsourcing
  • Criteria for outsourcing partner selection
  • Best practices in outsourcing
  • 11:40 THE OUTSOURCING AGREEMENT

    Paul Ranson

    Paul Ranson, Partner, Stringer Saul

  • Performance terms
  • Commercial terms
  • Confidentiality and intellectual property
  • Liability, warranties and indemnities
  • Termination issues
  • 12:20 Networking Lunch

    14:00 OWNERSHIP OF IPR GENERATED BY OUTSOURCING

    Hiroshi  Sheraton

    Hiroshi Sheraton, Associate Solicitor, McDermot Will & Emery

  • The rise of challenges to IPR ownership
  • Identifying problems
  • Costs and consequences of disputes
  • Effective management of disputes and alternative approaches
  • Preventative steps
  • 14:40 DEVELOPING DRUGS TOGETHER

    Edward Leung

    Edward Leung, Vice President, Preclinical Research & Development , King Pharmaceuticals Research & Development

  • Pharmaceutical development is a high-risk business
  • All companies outsource some of the activities in this long process.
  • Depending on the needs of the partners, several outsourcing models can be applied.
  • Regardless of the actual model used, a successful partnership will be enhanced by creating an environment which facilitates information flow and allows informed decisions to be made in a timely manner
  • Practices to help ensure success
  • 15:20 THE OUTSOURCING DILEMMA: HOW MUCH AND HOW MANY RESPONSIBILITIES AND FUNCTIONS?

    Stefano Marini

    Stefano Marini, Managing Director, Dimensione Ricerca S R L

  • Corporate and strategic trials: who should manage? Who should execute?
  • The process of selecting a strategy
  • The strategy of functional outsourcing
  • How to organise an outsourced functional clinical operation
  • How to monitor the performance of an outsourced functional clinical operation (key performance indicators)
  • What about penalties?
  • 16:00 Chairman’s Closing Remarks followed by Afternoon Tea

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Todd Hintze

    Todd Hintze, Healthcare Practice Group President , The Everest Group

    9:10 THE USE OF METRICS AND FORECASTING FOR

  • Over the years sponsors determined recruitment budgets by simply allocating a set amount-an average $5,000-to each site for local recruitment
  • 8 out of 10 times this approach results in budget waste, limited results and a study floundering to meet its timeline goals. The result; budget overruns, timelines missed and a frustrated clinical team
  • Why is this approach so severely flawed? Why does a "one-size-fits-all" approach set the study up for recruitment failure?
  • Elizabeth Moench

    Elizabeth Moench, President & CEO, Medici Group Inc

    Richard  Anderson

    Richard Anderson, Chief Executive Officer, De Facto Communications

    9:50 INTEGRATED OUTSOURCING SOLUTIONS

    Rosie McLaughlin

    Rosie McLaughlin, Director, Formulation, Cardinal Health

  • Do you need to outsource?     
  • Risks / benefits of the "one stop shop" approach
  • From concept to market
  • Case studies 
  • 10:30 Morning Coffee

    11:00 SOURCING INFRASTRUCTURE SERVICES AND PROJECT BASED APPLICATION DEVELOPMENT IN ASTRAZENECA

    George Partelow

    George Partelow, Global Programme Manager, AstraZeneca Corporate Office

  • The presentation will provide an update on our successes and challenges in outsourcing commodity infrastructure services across the US, UK and Sweden over the past 4+ years
  • The presentation will also provide an update on our experience in outsourcing application development for several large projects in AstraZeneca
  • 11:40 SUCESSFUL IMPLEMENTATION OF ENTERPRISE CALIBRATION MANAGEMENT SYSTEMS

  • Explore selecting, implementing and validating an Enterprise Calibration Management system in today’s global pharmaceutical corporation
  • GMP compliance no longer begins and ends in the quality assurance organisation
  • GMP processes must be closely monitored as the FDA is pushing for standardisation within these organisations
  • The need for a cost-effective, global Calibration Management Systems (CMS) is imperative
  • James Clifford

    James Clifford, Manager, Maintenance Systems , Wyeth

    Jake Michalik

    Jake Michalik, Enterprise Sales Manager, Blue Mountain Quality Resources Inc.

    12:20 Networking Lunch

    14:00 SETTING UP A MANUFACTURING OUTSOURCING CONTRACT

  • Identifying and evaluating product manufacturers
  • Requirements for GMP compliance – the technical agreement
  • Getting started – product transfer  
  • Managing the ongoing relationship
  • Vic Edy

    Vic Edy, Consultant, Newland GxP Consultancy

    14:40 Chairman’s Closing Remarks followed by Afternoon Tea

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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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