EU Enlargement With Croatia Comes Under Scrutiny

European Union enlargement with Croatia—as well as the latest changes to clinical trial legislation, innovation (products in the pipeline), transparency, and implementation of the pharmacovigilance legislation—will be discussed in-depth during a regulatory town hall meeting at the Drug Information Association's 26th Annual EuroMeeting.

As an indication of the importance being attached to the special session, Guido Rasi, Executive Director of the European Medicines Agency (EMA), will chair the event, along with Christa Wirthumer-Hoche, Deputy Head of the Austrian Medicines and Medical Devices Agency. Attendees can put burning questions to the panel of expert regulators, including Viola Macolic Sarinic, Head of the Agency for Medicinal Products and Medical Device in Croatia, which joined the European Union as its 28th member state on July 1, 2013.

According to an EMA statement issued in July, "Croatia is now part of the European medicines network and its representatives are fully involved in the activities of the seven scientific committees of the EMA as well as the agency's other activities. In January 2011, the EMA, together with the Croatian national competent authorities, started a pre-accession linguistic review of product information for centrally authorized medicines in the Croatian language."

The plan is to phase in European Commission (EC) decisions on centrally authorized medicines, thereby avoiding delays in the supply of medicines in Croatia. Also, the aim is to avoid peaks of activity for regulators and industry around the time of accession. Delegates at the EuroMeeting, to be held in Vienna March 25-27, 2014, will find out whether this strategy has worked.

Over 3,000 professionals from industry, government, and academia, plus students and representatives of patient groups, are expected at the congress. There will be more than 100 sessions in 17 parallel themes, and 350-plus expert speakers, including representatives from the EMA, EC, FDA, and European national regulatory agencies. In addition, there will be 14 pre-conference tutorials and over 170 exhibiting companies, the organizers noted.

A satellite meeting will take place about how to make Austria a more attractive research and industrial pharmaceutical location. Also, the clinical research track will focus on draft risk-based monitoring regulations, new technologies organizing aggregated sources of digital data, and how advances in behavioral sciences provide new responses to industry's search for optimized clinical research paradigms.

"What are the lessons learned and benchmarks to date in this new era of clinical research?" noted joint organizers Clara Heering, Senior Director Project Coordination Center, Western Europe, Quintiles, Belgium and Carl Naraynassamy, Director of Explicator, UK in the DIA 2014 EuroMeeting preliminary program. "We need to ascertain that the paradigm shifts are founded on robust assessments of risk and evidence of qualitative and effective processes; verify that investigators, monitors, and project managers are empowered in their decision making; and satisfy ourselves that the greater reliance on digital data enhances patient safety and ethical conduct of clinical research."

The e-clinical track will discuss how the past decade has increased the possibilities for speeding up, increasing quality, performing new types of studies and analyses, streamlining the data flow, and in general taking clinical development to the next level. The added value, implications and future perspectives of e-clinical will be presented in an understandable way to the various (non-technical) disciplines involved in pharmaceutical development, according to organizer Peter Stokman, Head Global Data Management & Standards Oss, Merck Sharpe and Dohme, Belgium.

Another session will look at how to involve and inform patients. It will give examples of what patients need to know about clinical trials, how to turn informed consent into an opportunity, best practice for patient advocates in clinical research today, how to effectively use social media and mobile devices to work with patients, and how to train patient advocates to be knowledgeable partners in clinical research.

"Well-informed patients and patient advocates have a key role to play in the implementation of patient-centered clinical research strategies and approval processes, access to treatments and treatment optimization approaches," stated Jan Geissler, Project Director of European Patients' Academy on Therapeutic Innovation. "In an era of growing demand and emphasis on both quality and sustainability of healthcare, it is critical to involve patients in the R&D process. In many disease areas, patients are already actively engaging in the many processes involved in the development of new treatments today, from contributing to protocol design, informed consent, and ethical review to the overall medicines development process, marketing authorization, and healthcare policy. Involving patients can accelerate research and make it more effective."