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Devising a well-constructed approach to Phase IV studies can be challenging. In today’s heavily regulated market the task is to meet and combine safety and clinical goals with regulatory compliance while achieving your company’s strategic objectives. While learning more about a drug’s side effects, long term risks and ‘real world’ results, attention must be made to accomplishing objectives in accordance with regulatory requirements and industry codes.
SMi’s Inaugural conference, Phase IV to Market will explore current perspectives and future trends in Phase IV study by introducing best practice advice on how to conduct Phase IV trials for clinical research and overcome key challenges while meeting your regulatory, clinical and strategic goals. Learn from the experts as they address current and future regulatory issues pertaining to the conduct of Phase IV studies including insights into what new regulations are being proposed, the impact on risk assessment, risk management programmes and compliance.
A panel of key industry experts from multiple companies and disciplines will share their experience, ideas and viewpoints on approaches to streamlining Phase IV trials and design, determining new indications for drugs going to market, implementing post-marketing surveillance and risk management strategies and the use and credibility of observational data in a post-market environment. Consideration will also be given to the use and application of pharmacoeconomics and patient reported outcomes (PRO’s) for clinical Phase IV and post-market entry. The conference will conclude by examining the development of an effective clinical plan and will provide insights into strategies to ensure your clinical plan meets strategic bjectives while adhering to regulatory requirements and industry guidelines.
·         PHASE IV STUDIES: Explore current perspectives and trends as we conduct an in-depth analysis of the increasing importance of Phase IV trials in clinical research
·         ACHIEVING REGULATORY COMPLIANCE: Learn more about a drug’s side effects, long term risks and ‘real world’ results while achieving your company’s strategic objectives while keeping in line with current and future regulation
·         STREAMLINING PHASE IV TRIALS: Hear from the experts as they discuss best practices for conducting current and future phase IV trials – building a strategy that achieves scientific credibility whilst maximising product exposure
·         INVESTIGATOR INITIATED STUDIES: Learn how to develop programme initiatives with a focus on strategy, responsibility and operations
·         PHASE IV AND RISK MANAGEMENT: Discover the merits of pre-approval risk management systems and strategies to support peri-approval RM plans
·         POST- MARKETING OBSERVATIONAL STUDIES: Key experts will provide insights into real-life clinical practice regarding safety, efficacy and patient drug compliance through the use of observational studies
·         PHARMACOECONOMICS AND PATIENT REPORTED OUTCOMES RESEARCH: Understand the application of Pharmacoeconomics and PRO’s for clinical Phase IV and post-market entry
·         DEVELOPING AN EFFECTIVE MEDICAL MARKETING PLAN: Learn how to develop the needs of your marketing and clinical departments for greater benefits and ROI

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Bernard Hart

Bernard Hart, Director, Clinical Science, AstraZeneca

9:10 PHASE IV TO MARKET

Michael Edwin Kafrissen

Michael Edwin Kafrissen, Chief Scientific Officer, Ortho-McNeil Janssen Scientific Affairs

  • Exploring current perspectives and trends
  • Traditional Phase IV studies - what is required?
  • What are the key objectives?
  • A drug to drug market comparison
  • Monitoring a drug’s long-term effectiveness
  • Evaluating the cost-effectiveness of the drug therapy vs more traditional therapies
  • Challenges and limitations
  • Ensuring a trial has scientific value vs promotional benefits
  • Phase IV studies - meeting safety, scientific and regulatory goals
  • The increasing importance of Phase IV trials in clinical research
  • 9:50 DESIGNING AN EFFECTIVE PHASE IV STUDY

    Bernard Hart

    Bernard Hart, Director, Clinical Science, AstraZeneca

  • Establishing the goals of the study and ensuring these objectives will be met in a strategic manner
  • What are the key design decisions?
  • Designing an effective post-launch safety surveillance system
  • Recognising medical needs and commercial concerns during the design process
  • How to capture and interpret data during the studies
  • Meeting scientific standards and conducting the study appropriately
  • 10:30 Morning Coffee

    11:00 PHASE IV PROTOCOL

  • Devising a plan to safeguard the health of the participants as well as answer specific research questions – the challenges
  • Deciding what types of people may participate in the trial?
  • Streamlining protocol development and product development times
  • Getting the data to the consumer – improving current timelines
  • The effect of a clinical trial protocol registry
  • Case studies
  • Imre Pavo

    Imre Pavo, Area Director, Medical & Regulatory Affairs, Central/Eastern Europe, Africa, Middle East & CIS, Eli Lilly

    Tamas Treuer

    Tamas Treuer, Director, Neuroscience Research in Area Medical Center Vienna, Eli Lilly

    11:40 NON-INTERVENTIONAL POST-AUTHORISATION SAFETY STUDIES (PASS)

    Martin Knight

    Martin Knight, Client Relationship Director, Clinical Operations, Covance

  • Rational for undertaking a PASS
  • What makes a study non-interventional – surely it’s obvious?
  • Recent changes to PASS guidelines
  • Current regulatory and IEC requirements
  • Practical recommendations for designing simple and cost effective studies
  • 12:20 Networking Lunch

    14:00 DEVELOPING INVESTIGATOR INTIATED STUDIES

    Lisa Wissinger

    Lisa Wissinger, ISS Manager, AstraZeneca Pharmaceuticals LP

  • Developing programme initiatives: strategy, responsibilities, operations
  • What are the benefits and pitfalls of IIS programmes?
  • Understanding the regulatory requirements
  • Defining successful delivery in regard to IISs
  • Designing investigator agreements
  • Working with investigators - contracts and communication
  • Project managing IIS programmes
  • New indications and label changes
  • 14:40 INVESTIGATOR SPONSORED TRIALS – REGULATORY ISSUES AND OPERATIONAL CHALLENGES

  • Regulatory overview
  • IST review criteria
  • Process and guidelines
  • Important issues
  • Karen Smith

    Karen Smith, Head, US Clinical Operations, Bristol-Myers Squibb Company

    John  Knapp

    John Knapp, Attorney-at-Law, Knapp & Associates

    15:20 PHASE IV STUDY OR PATIENT REGISTRIES

    Peter St Wecker

    Peter St Wecker, Senior Manager, Clinical Affairs, Genentech Inc

  • Discussing the benefits and limitations of both models
  • Drivers and shapers - choosing the model that best addresses specific research objectives
  • Are patient registries adequately controlled? Do they produce accurate and useful information?
  • Patient registries – allowing large-scale/long-term data collection in a cost-effective manner?
  • Which models provide a better insight into
  • reimbursement policy
  • healthcare system access
  • physician experience
  • patient reported outcomes
  • compliance
  • patient satisfaction?
  • What are the key considerations for managing an effective patient registry?
  • Can registries be run in the same way as a Phase IV study?
  • 16:00 Chairman’s Closing Remarks Followed by Afternoon Tea

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Cheryl Silberman

    Cheryl Silberman, Director, Medical Research, Takeda Global Research & Development Center Inc

    9:10 IMPLEMENTING POST-MARKETING SURVEILLANCE

    Dipti Amin

    Dipti Amin, Senior Vice President & Head of Global Medical & Regulatory Affairs & Drug Development Development Consulting Services, Quintiles (UK) Ltd

  • What constitutes post-marketing surveillance?
  • Understanding the importance of post-marketing surveillance
  • How does the post-marketing surveillance system (PMS) benefit the industry?
  • Does this effectively monitor the ongoing safety of marketed drugs?
  • Reassessing drug risks with new data – what can we learn?
  • How should this be implemented? Key challenges and limitations
  • How can risk be managed appropriately?
  • 9:50 PHASE IV STUDIES AND RISK MANAGEMENT

  • Pre-approval safety risk management systems and strategies in support of peri-approval RM Plans
  • Enhancing drug benefit-risk communication
  • Craig Hartford

    Craig Hartford, Executive Director & Site Head, Safety & Risk Management, Pfizer Global R&D

    Ferdinando Vegni

    Ferdinando Vegni, Director, Risk Management Strategy, World Wide Development, Pfizer

    10:30 Morning Coffee

    11:00 THE USE AND CREDIBILITY OF OBSERVATIONAL DATA IN A POST-MARKET ENVIRONMENT

    Campbell Howard

    Campbell Howard, Clinical Director, Novo Nordisk Pharmaceuticals Inc

  • A non-interventional, observational, epidemiological study aimed at addressing key issues
  • Translating data into scientific information – challenges and limitations
  • Use and credibility of observational data in a post-market environment
  • Using the data to identify patient populations for which the effectiveness may be altered or that are at high risk for adverse reactions
  • Handling missing data – examining statistical approaches to overcome this
  • Developing credible and effective observational studies
  • 11:40 PRACTICAL EXPERIENCES OF IMPLEMENTING EDC IN LATE PHASE STUDIES

    Alison Liddy

    Alison Liddy, Project Manager, Phase Forward

  • The value of EDC
  • Use of portals
  • Safety integration
  • Real life experiences
  • 12:20 Networking Lunch

    14:00 DEVELOPING STRATEGIES FOR THE MEASUREMENT OF PATIENT REPORTED OUTCOMES (PROs)

    Cheryl Silberman

    Cheryl Silberman, Director, Medical Research, Takeda Global Research & Development Center Inc

  • What are PROs and how are they measured?
  • PROs - demonstrating a product's clinical and economic value
  • Measuring and documenting patient reported benefits of a product
  • Assessing results from the perspective of patients, healthcare providers and payers, and government regulators
  • How does this information support product submission to the Food and Drug Administration (FDA)?
  • Implementing effective studies and capturing data
  • How best to analyse quality of life data and its use for product labelling
  • Useful strategies to translate the information into meaningful marketing messages
  • 14:40 INTEGRATING MEDICAL AFFAIRS WITH MARKET OBJECTIVES

    Pamela Clax

    Pamela Clax, Medical Director, US Medical, Anti-Infectives-HIV, Pfizer Inc

  • How do you improve the quality of late phase medical marketing research strategies?
  • Optimising medical marketing programmes that address business, science and educational objectives
  • Strategies to ensure that your clinical and marketing teams work effectively together to maintain successful relations
  • Methods to improve communication and structure
  • Ensuring your marketing programme has clinical relevance
  • Developing decision-making tools
  • 16:00 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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