Publications

Based on its intensive interactions with multiple key opinion leaders, SFL regularly publishes targeted opinion papers on prevailing or forthcoming changes to regulations and legislation that are relevant for stakeholders in the health care and life science sector.

Physicians prefer greater detail in the biosimilar label (SmPC)
This article reports the results of a survey among 210 physicians across seven EU countries on their preferences for the contents of a biosimilar label (SmPC). Overall, the results of this survey demonstrate that the vast majority of surveyed physicians prefer samples of a potential biosimilar label that include more information on the specific product compared with the current label. Notably, the physicians use the label as a main source of information, almost as frequently as professional guidelines and peer-reviewed publications. These results substantiate prior anecdotal evidence that physicians want more information in the label of a biosimilar medicinal product.
Regulatory Toxicology and Pharmacology 2016;77:275

The challenge of developing combination products
This commentary briefly describes what developers of combination products and in vitro diagnostics (IVDs) need to consider in the light of changing regulatory requirements and historically different approaches to product development in the pharma and medtech sector. Particular emphasis is put on the envisioned revisions of the Medical Devices Directive and the In Vitro Diagnostics Directive (both becoming regulations in the future), and the changing role and scrutiny of notified bodies.
MedNous 2015;9:18

Bridging the regulatory gaps for combination product makers
This report on the inaugural Medtech & Pharma Platform event held in October 2014 describes the challenges faced by industry during the lifecycle of combination products, ranging from development till reimbursement.
Scrip Regulatory Affairs;2015;February:1-2

EuroMeeting Report: The new regulatory outlook for medical devices and combination products
This brief report summarizes the session chaired by Shayesteh Fürst-Ladani at the 26th Annual DIA EuroMeeting in Vienna where representatives of the EU Commission, Competent Authorities, Notified Bodies and Industry shared their perspectives on the proposed changes in the forthcoming EU Regulations on medical devices and in vitro diagnostics. The proposed changes will significantly impact stakeholders; therefore, stakeholders should be monitoring ongoing regulatory developments closely and anticipating appropriate measures to ensure timely compliance.
Global Forum Reach;6:32-34

The new research rules in Switzerland versus the proposed EU Clinical Trials Regulation
This report written by the SFL team compares new rules governing clinical trials in Switzerland with the landmark trial reforms that are nearing completion in the EU.
Scrip Regulatory Affairs 2014;March:07

Company compliance
This article examines how greater focus on allegedly corrupt business practices in the pharma industry has led to increased compliance expectations.
European Pharmaceutical Contractor. December 2013:60-61

The Changing Environment for Pharma and Medtech Companies in Europe
Based on an SFL lecture and networking event held at the Institute of Directors in London, this article outlines the life sciences industry’s current operating environment and looks at some future challenges.
Pharmaceutical Physician. 2013;24(3):8-10

Putting a value on health and innovation – Examples from UK/EU and Switzerland
This article looks at ongoing developments in European healthcare and provides views from different angles, namely regulatory affairs, public affairs, legal and market access.
Pharmaceutical Physician. 2013;24:6-9

Combination products: adapting the EU regulatory framework to reality
In this article, SFL’s Managing Director, explains how the EU rules on combination healthcare products must avoid duplication of evidence gathering and of regulatory submissions and promote early dialogue between stakeholders.
Scrip Regulatory Affairs. 2013;May:13

SFL interviewed by the Basler Zeitung, a leading regional Swiss newspaper
Recently, SFL’s Directors were interviewed by the Basler Zeitung newspaper about the company and the services it provides to pharmaceutical and medtech companies. The newspaper covers the Basel metropolitan area, which is a thriving area for the life sciences sector.
Basler Zeitung, 2013;April 04:37

Providing solutions
Shayesteh Fürst-Ladani, SFL’s Managing Director, was recently interviewed by European Biopharmaceutical Review, about her future goals, advice for aspiring entrepreneurs and what the pharma industry needs to focus on.
European BioPharmaceutical Review 2013;April:88

Is the law jeopardising the future of human embryonic stem cell research in Europe?
This report written by the SFL team covers legal and political developments relating to human embryonic stem cell research in the EU and examines the implications for the innovative biotech industry. This article was published in the January 2013 issue of Scrip Regulatory Affairs.
Scrip Regulatory Affairs. 2013;January:9-11 

Succeeding in Switzerland's regulatory environment for pharma - similarities and differences compared with the EU
Critical differences between the Swiss and EU regulatory system that drug manufacturers should be aware of and how Swissmedic plans to shorten its review timelines.
Scrip Regulatory Affairs. 2012;November:9-11

Future good scientific publishing practice will necessitate wider data transparency
Important new recommendations on ‘Data Transparency’ and their impact on the publication of clinical trial results. This article aims to raise awareness about the increasing role of guidelines around the publication of biomedical research, their impact on authors’ efforts and, in case of non-compliance, potential impact on commercial trial sponsors.
Curr Med Res Opin. 2012;28:1881-1882

The calls for full data transparency
A report on the background of growing calls for increased data transparency and some critical aspects to be considered before implementation of new transparency rules. This article is based on a presentation and workshop held by SFL's Senior Communication Manager Faiz Kermani, at the University of Cardiff's Postgraduate Course in Pharmaceutical Medicine.
Pharmaceutical Physician. 2012
;23:17-21

How the EU Regulatory Environment is Changing for Drug/Device Combinations and Companion Diagnostics
A report on DIA Europe’s Combination Products Workshop by the Programme Co-chair Shayesteh Fürst-Ladani, Managing Director, SFL Regulatory Affairs & Scientific Communication Ltd, Switzerland.
Global Forum. 2012;4:79-81

Device Advice
Current regulations concerning medical device combination products often prove to be complex and confusing. However, changes to guidance in the EU and US may help to simplify the challenging process of product classification.
European Pharmaceutical Contractor. 2012;Autumn:30-34

The Regulators’ Role in Innovation
The regulators’ role pharma innovation is critical and should not be overlooked.
Regulation & Innovation. 2012:11-15

Is this the year of more clarity in the EU for products on the pharmaceutical/medical device borderline?
The pharma and medical device industry is witnessing the exciting potentials of medical technology to deliver drugs, of diagnostics to assess drug efficacy and of rapid electronic communication to better enable healthcare staff monitoring patients remotely. However, under which regulations or directives do these products fall, and who is the relevant regulator?
Pharmaceutical Physician. 2012;23:12-14

Providing Future Opportunities for Clinical Trial Partnerships in the UK
The UK has traditionally been a strong performer in terms of R&D for drug development. How is the UK attempting to maintain/improve its involvement in European and global clinical trials?
Pharmaceutical Physician. 2012;22:13-16