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This workshop gives a regulatory/ legal perspective on paediatric investigation plans, the paediatric procedure, other obligations imposed by paediatric regulation, the sanctions for non-compliance and the rewards.
We will start with the very first question of whether a PIP is required and end with the very last stage of applying for a reward. We will also examine the best practices with regard to the content of a PIP and the procedure.

• Gain detailed insight into the EU paediatric legislation
• Understand the overall functioning of the paediatric system and the best approaches thereto
• Learn about the best practices when defining the content of the PIP
• Learn about the best practices when dealing with regulatory procedures
• Maximise the chances of obtaining a reward

Directors, Chiefs, VPs, Heads, Managers, Principals of:

- Clinical Trials/ Paediatric
- Clinical Research
- Medical Officer
- Regulatory Affairs
- Clinical Operations
- (Paediatric) Drug Development
- Drug Formulation
- Medical devices
 


 

Workshop LEADER

keynote-img

Genevieve Michaux

Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP

Geneviève Michaux is a partner in the Government & International Trade group of Mayer Brown's Brussels office. She is a Belgian- and French-qualified lawyer who focuses on European and national (French and Belgian) food and drug law, with particular emphasis on issues surrounding the regulation of drugs, biologics, medical devices, cosmetics and food both at the Union and national levels.


Her work covers a wide range of issues, including regulatory status of borderline products, life cycle management, clinical trials and investigations, labeling and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. Geneviève provides assistance to companies on important new legislative projects and policy developments in the EU. She regularly instructs and supervises local counsels for pan-European or worldwide projects. She also has broad litigation experience in life science matters, including product liability, advertising and promotional activities, and generic approvals.


Geneviève is recognized as one of the "Most Highly Regarded Individuals" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an "unsurpassed knowledge of legal areas," as well as being "extremely dedicated to the case and the client." She has published a number of articles on food and drug law and regularly speaks at legal and regulatory conferences on pharmaceuticals and medical devices.
 

Mayer Brown LLP

At Mayer Brown We offer the legal and technical experience and global awareness needed to understand the opportunities offered and challenges presented to these industries.


Our Life Sciences group consists of a multidisciplinary team of lawyers with extensive industry knowledge and resources. The group comprises lawyers from across the firm’s practices. These lawyers are experienced in dealing with the issues affecting the life sciences industries globally, including: transactions, intellectual property (IP), dispute resolution, antitrust and competition, risk management, investigations and compliance, government and global trade, tax and transfer pricing, and regulatory and environmental matters.

Workshop programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Genevieve Michaux

Genevieve Michaux, Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP
View Bio

9:10 SESSION 1 – Do I need a PIP?

Genevieve Michaux

Genevieve Michaux, Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP
View Bio

  • Exemptions
  • New active substances
  • 'Old' (authorised) active substances
  • 9:50 SESSION 2 – What should the PIP cover?

    Genevieve Michaux

    Genevieve Michaux, Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP
    View Bio

  • EMA Policy on the Content of the PIP
  • Waiver
  • Deferral
  • 10:30 Morning Coffee

    11:00 SESSION 3 – Procedures

    Genevieve Michaux

    Genevieve Michaux, Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP
    View Bio

  • Paediatric Procedure: PIP and PIP modification
  • Interactions with the Marketing Authorisation Procedure: from compliance check to authorisation of a paediatric indication
  • 11:40 SESSION 4 – Rewards

    Genevieve Michaux

    Genevieve Michaux, Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP
    View Bio

  • Extension of supplementary protection certificate (SPC) protection
  • Orphan products: extension of market exclusivity protection
  • PUMA
  • How to maximise the chances of obtaining a reward
  • 12:20 Closing Remarks

    Genevieve Michaux

    Genevieve Michaux, Member of the Brussels and Paris Bar, Partner, Mayer Brown LLP
    View Bio

    13:50 End of workshop

    +

    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.

     

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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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