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SFL’s Managing Director and Head of UK Office to Speak at DIA Combination Products Workshop in Basel, Switzerland

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SFL’s Managing Director and Head of UK Office to Speak at DIA Combination Products Workshop in Basel, Switzerland Powered By Docstoc
					  SFL’s Managing Director and Head of UK Office to Speak at DIA Combination Products
                            Workshop in Basel, Switzerland


SFL will present at a one-day conference to provide delegates with an understanding of the
regulatory framework for drug/device combinations and drug/companion diagnostics in the
EU.


SFL is pleased to announce that Shayesteh Fürst-Ladani, Managing Director of the company
and Amanda Maxwell, Head of the UK office of SFL, will be chairing sessions and speaking at
the DIA’s upcoming Combination Products Workshop to be held on 18 September in Basel,
Switzerland.
The workshop entitled “Anticipating the New Regulatory Landscape for Drug/Device
Combinations and Companion Diagnostics: an Overview of the Current and Likely Future EU
rules”, will provide delegates with a critical and timely insight into the changing regulatory
landscape for these often complex and unique products.
The one-day workshop will focus on the differences between device and pharma regulations
and highlight challenges facing manufacturers, who need to comply with elements of both
regulatory structures. Furthermore, guidance to those who operate on the drug/device
borderline where it is not immediately obvious which regulatory framework applies will be
given. The workshop is particularly important given the latest discussions at European
Commission on the revision of the European medical device and in-vitro diagnostics (IVD)
legislations expected to be published end September 2012.
In her speech, Shayesteh will provide an overview of Commission discussions on the
proposed revision of Medical Device Directives and current and changing regulatory
framework for combination products in EU/US. She will also chair the session “Stakeholders’
roles in assessing combination products in the EU”, which will give an overview of future
regulatory expectations among Notified Bodies, National Regulatory Agencies and the EMA,
and of their experiences to date with combination products. It will also give an outline of
legal criteria for determining the correct classification of borderline products.
Amanda will be chairing and speaking at the session “Regulatory requirements for
companion diagnostics in the EU”, which will give attendees with an overview of the
development and approval of Companion diagnostics. In her presentation, Amanda will
provide an overview of Commission discussions on the proposed revision of the IVD
Directive.

                   SFL Press Release – September 5, 2012 | For General Release
“Manufacturers of drug/device combination products and borderline products will be
impacted by an increasingly strict regulatory environment in the EU,” commented
Shayesteh. “It is essential that all stakeholders in this sector keep abreast of the changes
and ensure that they remain legally compliant. This workshop will be valuable for attendees
in providing information on how the new legislations are likely to change their day-to-day
business.”
About SFL Regulatory Affairs & Scientific Communication Ltd
SFL provides a holistic approach to lifecycle management of healthcare products from pre-
clinical studies and clinical trials through to registration and post-approval activities. The
company’s team of professionals have experience in Regulatory Affairs, Public Affairs, Legal
Services and Medical Communications. SFL supports its clients by offering personalized and
comprehensive services. When combined, these services provide an integral oversight
package for products from the bench to the marketplace at one consultancy.



For more information, please contact:

SFL Regulatory Affairs & Scientific Communication Ltd

Hochstrasse 51,

CH-4002 Basel,

Switzerland

Tel: +41 61 361 9443

Fax: +41 61 361 9442

Email: office@sfl-services.com

Web: www.sfl-services.com
                                                             A Holistic Approach to Lifecycle Management of
                                                                           Healthcare Products




                   SFL Press Release – September 5, 2012 | For General Release

				
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Description: SFL will present at a one-day conference to provide delegates with an understanding of the regulatory framework for drug/device combinations and drug/companion diagnostics in the EU.