Enhancing Observational Research To Demonstrate Drug Safety, Effectiveness & Quality

Event Overview

Observational studies are increasingly becoming an important tool for pharmaceutical companies in the post-marketing research phase. Regulatory agencies like the FDA and EMEA are demanding more patient data, and purely clinical evidence is now no longer seen as sufficient as it once was. Data achieved through non-interventional studies is now being viewed by regulators as a necessary bridge between the clinic and the real world. In the quest towards providing realistic evidence-based medicine, observational studies are becoming viewed more and more as a vital element for pharmacovigilance programmes in order to enhance commercial opportunities.

Health technology assessment agencies and payers are also increasingly requesting more information that supports the cost-effectiveness claims from pharmaceutical marketers. Observational data achieved through the establishment of patient and disease registries, compliment existing clinical programmes. This provides the longer-term and real-life evidence that allow both regulators and HTA agencies to be more confident in their decisions, to the benefit of the pharma industry, payers and patients alike.

The event will bring together a strong panel of speakers and will explore their unique approaches and techniques in order to maximise observational research performance. Together we will be examining the growing role of non-interventional research in achieving stronger safety results, improved cost effectiveness outcomes and improved drug performance.

Why attend?

• Find out when to run observational studies, for what purpose, where, what size and how they should be designed.
• Learn how patient and disease registries can be utilised to enhance pharmacovigilance and market access campaigns.
• Hear the real-life experiences of those who have successfully performed observational studies and how they overcame significant challenges.
• Listen to what is considered best practice in non-interventional research, by understanding the strategic & operational perspectives and the practical challenges.
• Question the views and opinions of regulatory authorities and health technology assessors.

Who will benefit:

Pharmaceutical & biotech companies
Vice Presidents, directors & managers of:
Medical Affairs, Epidemiology, Clinical Development & Operations, Drug Safety, Pharmacovigilance, Market Access, Marketing, Health Economics & Outcomes, Pricing & Reimbursement, Data Management, Regulatory affairs, Clinical Outsourcing

Solution providers:
CROs, EDC & Data Management, clinical software, market access & health outcomes consultancies.

Academics & doctors:
Epidemiology, principle investigators, primary care

Government:
Ministries of Health, Regulatory & Health Technology Assessment Agencies

Confirmed Speakers/Panelists

Contact Details

For Booking Information:
Tel: +421 232 662 621
Fax: +421 232 662 622
Email: observational(at)nextlevelpharma.com
Visit: www.nextlevelpharma.com

About the venue

Renaissance Hotel - The Imperial Riding School, Vienna, formerly known as Renaissance Penta Vienna Hotel, is set within the diplomatic area in an exquisite neo-classic hotel and the former home of an imperial riding school.

Our historic hotel offers the ideal location for business or leisure travel. Vienna relishes in its reputation as the centre of art and culture with its world-renowned theatre, fine arts and music. Walk to the impressive Castle Belvedere or visit the extraordinary Tutanchamun exhibition in Vienna! Our guest rooms feature luxury bedding, Internet, mini-bar, safe and air conditioning.

When planning a social or business event this is the place to stay.