The 28th SIMeL National Congress will be held in the "Palacongressi" Congress Center in Rimini on October 29-30th, 2014.

More details about the 28th SIMeL National Congress may be found on the website here : http://www.mafservizi.info/cms/it/simel-2014

 

The EU paediatric regulation is now in force since 2007. Drug development is no longer possible without considering children. Furthermore, companies developing medicines need to consider the paediatric requirements early in the development. This legislation has transformed paediatric drug development from a topic discussed by a few interested paediatricians, clinical pharmacologists and regulators to an issue that is broadly known within pharmaceutical industry and regulatory authorities, and to a lesser degree in the clinical world. More than 1000 PIP decisions are now published on the EMA website, and virtually everybody within pharmaceutical industry has heard of paediatric investigation plans and waivers. The EU Commission has published a 5-year report, and a 10-year report will be submitted by the Commission to the European Parliament and Council in 2017. 

The aim of this conference is to discuss on a high level how the EU paediatric regulation is working and how it contributes to children’s health. This will include a discussion on the preparedness for the 10-year report; strategic thoughts within the EMA on how to streamline paediatric development and a session dedicated to paediatric oncology. 

As always, experts from all involved parties will be present, and on day 1 participants will discuss more specialized and hot topic issues in four breakout sessions. This will allow participants to discuss face-to-face with all stakeholders, which otherwise usually occurs by email or phone. Questions on any topic relating to the Agency’s activities can be submitted before the conference to paediatrics@efgcp.eu, and will be answered by the Paediatric Medicines office at the EMA.

A revision of the Clinical Trials Regulation has been adopted by European legislation makers. This revised framework will bring significant advances compared to todays’ situation. However, the original objectives of this legislation should be remembered: these were to enhance efficiency of the overall clinical trials authorization process and, in turn, to boost the EU’s competitiveness as a place to conduct research and make for more efficient patients access to new innovative treatments.

Especially the procedure for assessment and approval of multinational clinical trial authorisation applications will change: in future, each Member State will have to generate one single opinion and the competent authority of the “reporting Member State” will coordinate the assessment process until a common decision is reached. Ethics committees are supposed to be an essential part of this assessment process but it is left to the Member State to decide how this will be achieved.    

Today, we are at a critical stage in the process where the new rules have to be integrated into the national systems in each Member State. When establishing procedures at national level, it is now essential that Ethics Committees find ways to ensure both a reliable independent ethical review delivered within the defined time frame as well as the relevant level of collaboration during the process with the national competent authority. This will require a re-thinking of ethical review processes and Ethics Committee infrastructure in most Member States. Early discussion with Ethics Committee members and competent authorities from other countries and with concerned stakeholders could help to define the  optimal solutions and support the development of a streamlined and a more harmonised system for the European Union.

This workshop aims to facilitate an exchange of opinions on opportunities and threats of the new CTA assessment requirements for the ethical review. It will also be an opportunity for early feedback from some Member States on potential concepts and options for the successful collaboration between ethics committees and competent authorities. Learnings from real life experience over the past decade will be used to identify the most critical aspects for different stakeholders: ethic committees, competent authorities, patients, investigators, commercial and non-commercial sponsors. Specific national hurdles that need to be overcome in the Member States will be identified to enable Europe to emerge as an attractive place for conducting Clinical Research.

OMICS Group is hosting 2^nd International Summit on Clinical Pharmacy during December 02-03, 2014 in San Francisco, USA. Clinical Pharmacy International Conference 2014 will be organized around the theme "Implementation of Advances and Challenges in Clinical Pharmacy." To explore the theme of Clinical Pharmacy-2014 over the world which is noticeable with the presence of more than 300 renowned scientists, students and business delegates representing from different countries ultimately driving the Pharma event into the path of success. By great response received from the Editorial board and Conference committee, OMICS Group International Conferences proudly announces the initiation of this esteemed Conference, to anticipate audience for this event includes with leading researchers, industry professionals, scientists, pharmacists and scholar students to exchange and share their experiences. Clinical Pharmacy-2014 is integrated by 16 tracks and 104 sessions considered to offer comprehensive sessions that address current topics in Clinical Pharmacy. Clinical Pharmacy-2014 which is also a scientific conference that offering to join for workshop on International Forum on Coffee and its Health Effects: pre-clinical studies ‘in vivo’ and ‘in vitro’, clinical and epidemiological evidences which is going to facilitate by Dr. Roseane Maria Maia Santos, South University School of Pharmacy, USA.
 

Event website

 

Click HERE for more information.

The value and importance of investigator-initiated trials (IITs) are broadly accepted in healthcare. Treatment optimization, exploration of new indications, head-to-head comparison of new medicines, investigation of long-term treatment outcomes and/or efficiency of treatments are important tasks of the medical community. Like for pharma company-initiated trials the overall responsibility for the trials lies also in IITs with the ‘Sponsor’. But in contrast to privately sponsored studies the infrastructure to fulfil these sponsor obligations is not always available in an academic environment. The complex legal, regulatory, financial and organisational requirements are not reliably known in the investigator-, hospital- and university- community interested and engaged in doing clinical research. In addition, the legal conditions for academic sponsorship vary from country to country which makes the organisation of multinational trials even more difficult.

This workshop aims at bringing together investigators, academic organisations, hospital and university administration representatives, regulators, ethics committee members, lawyers, pharmaceutical companies, SMEs and patient representatives from different countries to learn about different approaches to sponsorship and public-private partnerships in conducting clinical trials in different countries. Focus will be on different sponsor tasks and business models, contracting and training. As a result of these multi-stakeholder discussions it is intended to support professionalism in IITs through working out recommendations for facilitating and harmonizing the framework and organisation for investigator-initiated clinical research.

Indemnity coverage of subjects enrolled in clinical trials is a vital ethical pre-requisite and an important element in Good Clinical Practice (GCP).

Ensuring fast and easily accessible coverage of healthcare costs for healthy volunteers and patients enrolled in clinical trials with drugs who experience any kind of damage – independent of a potential causal relationship with the study medication – is a formal sponsor obligation. However, especially in academically sponsored studies the current level of insurance fees to be paid to insurance companies becomes prohibitive to independent academic drug research.

The requirement in the Directive that, “provision has been made for the insurance or indemnity to cover the liability of the investigator and sponsor,” has been interpreted differently in different member states, meaning that separate insurance is needed and different models of covering exist from country to country. Insuring international trials is not only very costly, it is also bureaucratic and complex.

In addition, this patchwork of regulation results in the ethically dubious position that patients taking part in the same trial in different countries, have different levels of insurance protection. In their Draft Regulation on Clinical Trials the European Commission is proposing that the national health care systems cover the liability for patients in – at least – the publicly sponsored clinical trials.

This suggestion is opposed by different Member States and stakeholder groups for a variety of reasons. As the period for consensus finding is coming to an end it appears important to bring representatives from different stakeholder groups together to evaluate the pro’s and con’s of existing national practices and conditions in Europe, to achieve a better understanding of the needs and expectations of the different stakeholders and to work out pragmatic recommendations that could satisfy stakeholder needs while preserving European attractiveness for biomedical research.

Science-based pharmacy education towards better medicines and patient care

Ljubljana, Slovenia

The risks and benefits of research remain a central consideration in drug development, research design, review and regulation. It’s consequently a central concern within the new proposed EU Clinical Trial Regulations.  

 

Yet there is little evidence on which to build our judgments and found a balanced approach. Without evidence, risks are exaggerated and the benefits played down. Medical and drug development is undermined, researchers are cautious, monitors without clear and appropriate objectives and as importantly potential research participants ill- or un-informed. We all lose. There is therefore an urgent need for re-evaluation and a coordinated approach to resolve these problems. Our conference will explore the consequences of research, both harm and benefit and look how we might achieve a fair balance that promotes improvements in health care, new medicines without diminishing protection of the research participant. It will also explore the current proposal for an EU Clinical Trial Regulation and its consequences. 

 

It will particularly address 

• the approaches of the EU, the EC, competent authorities and drug regulators
• roles of funders and sponsors
• how patients, researchers and ethics committees perceive and assess this balance
• how research risk is monitored
• how insurance and indemnity is and will be approached in the EU
• the representation of research risk and benefit in the media

 

For twenty one years the European Forum for Good Clinical Practice has acted as a forum to bring all parties with an interest in health care research together and debate current topics. It has members and partners in all areas of research so this conference will be an opportunity to contribute to the debate, influence policy and practice.

 

Plenary sessions:

 

1. The approaches of the Competent Authorities: How are regulators and member states approaching risks and benefits assessment?
2. Risk management, insurance and indemnity to include the principles of risk assessments and available tools as well as how brokers approach risk assessment
3. The Joseph Hoet lecture on ethics in clinical research: The Media and Research, Risk and Benefit Dr Trish Groves, Deputy Editor, British Medical Journal (BMJ), United Kingdom
4. The views of patients, researchers and ethics committees when considering harms and benefits. What matters to patients? How do researchers and ethics committees perceive and weigh up this balance? On what should they build their calculus?
5. Harms, benefits, risks and the new EU Clinical Trials Regulations