Home
overview
Workshop Overview:
This workshop will share knowledge of innovative regulatory strategies and provide practical advice of how they can be implemented in a generics organisation. Case studies and practical examples will be worked through demonstrating route to market strategies that ensure maximum value and speed to market. Competitive positioning strategies will also be discussed and these will include how to potentially use orphan designation to extend market exclusivity periods.

 Reasons to attend:

  • Understand innovative regulatory strategies to allow you to move your products forward in the most efficient way
  • Practical advice through the use of case studies that can be applied for your organisation
  • Understand the routes to market: MRP, DCP & Centralised procedural routes discussed and explained
  • Understanding the routes to market strategy for generics: MRP, DCP & Centralised procedure.
  • Creative regulatory strategies to extend market exclusivity for generic products: Including orphan designation in your strategy
  • Competitive positioning fixed dose combination development products: Understanding the regulatory implications 
About the workshop leader:
Dr. Graham has over 25 years’ experience within the pharmaceutical industry and has worked for several different companies including Glaxo, Merck & Co, IVAX and Amgen. Dr. Graham has held a number of Directorships including European Director of Regulatory Affairs at Amgen.  Dr. Graham founded Diamond Pharma Services in 2005, which is a leading technical and scientific consulting group of companies serving the biotechnology and pharmaceutical industry. Dr. Graham has direct experience with many types of products including biotechnology, advanced therapies and chemical entities. Dr. Graham also has a wealth of experience and expertise when it comes to the regulatory and product development issues associated with generics.

 

About Diamond Pharma Services:
Diamond Pharma Services (www.diamondpharmaservices.com) is a leading technical and scientific consulting group with an emphasis on the following areas:

Regulatory Affairs: Product Concept to Registration and Beyond
Product Development: Nonclinical, CMC and Clinical Aspects
Pharmacovigilance: Clinical trial (Phase I-IV), Post-Marketing and QPPV Services
Compliance: GLP, GMP, GCP and QP Services

The organisation has extensive experience across European Regulatory Affairs including New Chemicals, Biotechnology, Advanced Therapy products and Generic products.

 

 

  • Understand innovative regulatory strategies to allow you to move your products forward in the most efficient way
  • Practical advice through the use of case studies that can be applied for your organisation
  • Understand the routes to market: MRP, DCP & Centralised procedural routes discussed and explained
  • Understanding the routes to market strategy for generics: MRP, DCP & Centralised procedure.
  • Creative regulatory strategies to extend market exclusivity for generic products: Including orphan designation in your strategy
  • Competitive positioning fixed dose combination development products: Understanding the regulatory implications

About the workshop leader:
Dr. Graham has over 25 years’ experience within the pharmaceutical industry and has worked for several different companies including Glaxo, Merck & Co, IVAX and Amgen. Dr. Graham has held a number of Directorships including European Director of Regulatory Affairs at Amgen.  Dr. Graham founded Diamond Pharma Services in 2005, which is a leading technical and scientific consulting group of companies serving the biotechnology and pharmaceutical industry. Dr. Graham has direct experience with many types of products including biotechnology, advanced therapies and chemical entities. Dr. Graham also has a wealth of experience and expertise when it comes to the regulatory and product development issues associated with generics.
 

About Diamond Pharma Services:
Diamond Pharma Services (www.diamondpharmaservices.com) is a leading technical and scientific consulting group with an emphasis on the following areas:

  • Regulatory Affairs: Product Concept to Registration and Beyond
  • Product Development: Nonclinical, CMC and Clinical Aspects
  • Pharmacovigilance: Clinical trial (Phase I-IV), Post-Marketing and QPPV Services
  • Compliance: GLP, GMP, GCP and QP Services

The organisation has extensive experience across European Regulatory Affairs including New Chemicals, Biotechnology, Advanced Therapy products and Generic products.
 

Workshop programme

8:30 Registration & Coffee

9:00 Welcome and Introductions

9:10 Understanding the routes to market strategy for generics: MRP, DCP & Centralised procedure

9:50 Creative regulatory strategies to extend market exclusivity for generic products: Including orphan designation in your strategy

10:30 Morning Coffee

11:00 Competitive positioning fixed dose combination development products: Understanding the regulatory implications

11:40 Discussion Session / Q&A

12:20 Close of workshop

+

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.

 

HOTEL BOOKING FORM

Title

SubTitle
speaker image

Content


Title


Description

Download


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

Event Title

Headline

Text
Read More

I would like to speak at an event

I would like to attend an event

I would like to sponsor/exhibit at an event

SIGN UP OR LOGIN

Sign up
Forgotten Password?

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
Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
Registered in England No: 3779287 VAT No: GB 976 2951 71




Forgotten Password

Please enter the email address you registered with. We will email you a new password.