At this year’s DIA EuroMeeting, 25-27 March 2014 in Vienna, NDA Group participates with a full contingent of senior experts and consultants to engage with life science companies in all stages of development. For the first time, NDA will unveil the strategic biotechnology services portfolio that the company has been building up over the past year.
“ATMPs and gene and cell therapies will provide us with the next great leap in healthcare advances. It is still early days, but these novel technologies are no longer all in their infancy and experience and understanding are gradually being built up around the world. The expansion is easy to see just from the booming number of Scientific Advice procedures for these types of products in recent years. We’re looking at a veritable explosion,” said NDA Group CEO Johan Strömquist.
“The challenges are, however, significant – for many it’s a matter of walking a path tread by only a very small number of experts. Fortunately, many of those experts are part of the NDA team, some which have joined us as recently as last autumn. This means that there is now easy access to a growing experience and expertise through the services that we keep developing,” Strömquist continued.
During the EuroMeeting, NDA will have leading biologics experts on call and as speakers on key issues. These experts include NDA Advisory Board members Paul Chamberlain, Prof. Beatriz Silva Lima, Prof. Steffen Thirstrup and Dr. Jenny Sims. During the event, Jenny will present on Non-clinical development strategies for biosimilar monoclonal antibodies on Thursday 27th March and Beatriz is presenting on Innovation in pre-clinical and clinical safety sciences the same day.
NDA will also be showcasing the company’s biotechnology capabilities, encompassing ATMPs, biosimilars and biotechnology services. To find out more, please visit us at the event.
Increasing importance of Risk Management
NDA Group will also be presenting its complete portfolio of pharmacovigilance services at the DIA this year. EX-MHRA experts Morell David and Bridget King, alongside Dr. Brian Edwards, will be on hand to discuss the challenges and opportunities companies face. All three are holding workshops during the event, where Morell David and Bridget King will present on Signal Management (Tutorial 3 | Tuesday, 25 March, 09:00-12:30) and Dr. Brian Edwards will discuss Systematic approaches to deliver quality (Thursday, 27 March 16:00-17:30).
“Pharmacovigilance and Risk Management have become increasingly important parts of new drug approvals and for ensuring that products can stay on the market. Risk management should be factored into a drug’s development, to set the right expectations and focus the evidence generation on the right areas,” said Strömquist. “As a strategic risk management partner, our aim is to support clients factoring in risk management earlier in the lifecycle to ensure decisions are made based on the right information. In addition, we help ensure that any post authorisation commitments are relevant and managed in a way that optimises the product’s benefit / risk ratio, as well as ensuring that the activities are kept cost efficient.”
Hear NDA experts discuss key pharmaceutical issues
NDA’s experts have been invited to present on numerous pressing topics at this year’s DIA Euro meeting, including:
- Ex MHRA regulators: Morell David and Bridget King (pre-conference tutorials, Tutorial 3 | Tuesday, 25 March, 09:00-12:30)
Signal Management – the practical tools needed to address signal management, whether you are a small company or large organisation
- Dr. Markku Toivonen (Session 0403 | Wednesday, 26 March, 14:00-15:30) Developing Medical products for older people – Getting on track
- Prof. Beatriz Silva Lima (Session 1406 | Thursday, 27 March, 11:00-12:30)
Innovation in pre-clinical and clinical safety sciences
- Dr. Jenny Sims (Session 1407 | Thursday, 27 March, 14:00-15:30)
Non-clinical development strategies for biosimilar monoclonal antibodies
- Dr. Brian Edwards (Session 0607 | Thursday, 27 March, 14:00-15:30)
Workshop: Systematic approaches to deliver quality: Learn from the experts!
(Session 1008 | Thursday, 27 March 16:00-17:30)
Regulatory simplification: vision, oxymoron, or “mission impossible”?
Alongside the presentations above, NDA Group has a team of experts present at the DIA that will be available to engage in discussions from our stand x.701 – x.800.
To find out more or schedule an appointment with members of the NDA team, please visit www.ndareg.com or email email@example.com.
NDA media contact: Paula Warmer, email: firstname.lastname@example.org, mobile: + 44 (0) 7713 308314
NDA is an independent consulting group based in Germany, Sweden and the United Kingdom. Its mission is to ensure that good medicines reach patients without unnecessary delay. It accomplishes this by providing the pharmaceutical industry with a comprehensive range of professional services within regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. NDA’s team comprises more than 25% ex-regulators from major EU Agencies, plus two specialist Advisory Boards, consisting of Europe’s leading regulatory and HTA experts. They are there to provide scientific advice to pharmaceutical companies supporting them in gaining fast and constructive assessment of drug approval applications from European regulatory agencies and payer bodies.