The Programme

Registration

Opening remarks from the Chair

Assessing the likelihood of regulatory and ethical harmonisation

• Assessing the post-market regulatory environment and outlining cases where the principle of subsidiarity applies
• Considering auto-regulation and enforcement and their effects worldwide
• Discussing future global developments in regulatory and ethical compliance

Clinical evaluation: challenges of statutory requirements

• 2007/47/EC: new aspects regarding
  clinical data
  
• Clinical evaluation: general requirements
  
• Clinical data issues: pitfalls to avoid

Considering the need for clinical evidence

• Reviewing new requirements for design dossiers to develop clinical evidence for high regulatory class devices
• Exploring possible evidence gaps and establishing the need for post-marketing follow-up
• Clarifying the assessment of adverse events and reporting them

Outlining the achievements of the Global Harmonization Task Force (GHTF)

• Describing GHTF's global medical device regulatory model
• Allowing convergence of worldwide regulations within GHTF guidelines
• Analysing the constraints of global harmonisation in MD compliance
• Identifying future perspectives of the GHTF regulatory model

Global Harmonisation Task Force: combination products initiative

• Describing the GHTF Ad Hoc Group (WG) and current  work 
• Scope of the work
• Clarifying additional liaisons to be considered and steps moving forward

Explaining regulatory compliance for drug-device products

1. Reviewing the current regulatory framework and amendments in Directive 2007/47/EC
2. Assessing gaps in these guidelines
3. Considering the challenges of complying with obligatory EMEA regulations due to new procedures
4. Establishing strategies for ensuring regulatory compliance for combination products

Clarifying FDA guidelines for medical devices

• Highlighting the key changes to FDA regulations over the past two years
• Discussing major constraints prohibiting
• European manufacturers from complying with its regulatory framework
• Identifying strategies for ensuring FDA compliance for European device manufacturers
• Describing common practical approaches

Establishing the effects of international misconduct on the European market

• Discussing the increased regulatory and media scrutiny placed on medical device manufacturers
• Describing examples of illegal behaviour in terms of international medical device compliance
• Analysing their effects on the risk profiles of European companies
• Clarifying strategies to handle this

Ethics and compliance in Europe: challenges and opportunities

• Ethics and compliance in the medical device field: changes and challenges that we are facing 
• What are the opportunities?
• Relationship between medical device companies and healthcare professionals: the four principles and transparency aspects
• Zimmer’s visions

Closing remarks from the Chair and close of Day One

Registration

Opening remarks from the Chair

Michelangelo Stefani
General Counsel EMEA
COVIDIEN

Roundtable discussion 1
Discussing distributor and other third parties compliance with Foreign Corrupt Practices Act (FCPA) and anti-corruption law

Roundtable discussion 2
Assessing barriers to corporate codes of conduct and how to handle them

Outlining how processes can be amended to comply with the future regulatory framework

• Identifying which parts and processes will be affected relating to global convergence and international standardisation
• Defining efficient restructuring procedures while meeting standards constantly
• Analysing how to keep processes flexible for further changes

Roundtable discussion 3
Optimising business process management to achieve global compliance

Lunch

R. Richard Boncy
Head of International Relations
VENTURA GARCES &
LOPEZ - IBOR ABOGADOS

Codes of conduct for medical device companies

• Outlining common codes of conduct guidelines
• Highlighting why they fail with regards to ethical compliance
• How to help ensure their effectiveness

Dr. Dirk Wetzel
Head of Division Medical Devices
BFARM

IFUs for medical devices

• Regulatory framework
• Examples of shortcomings, pitfalls and solutions
• Reflection of clinical evaluation in the IFU
• Updating mechanism for IFUs
• Room for regulatory changes

Claire Murphy
Associate Consultant
TECNO-MED INGENIEROS

Understanding local/regional compliance requirements as part of a global compliance plan

• Explaining the transposition of European Medical Device Directives to Spanish legislation
• Outlining Spanish regulatory guidelines and local procedures
• Assessing communications and practices with Competent Authorities and Notified Bodies

Closing remarks from the Chair and close of conference