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September 2019: Drug Regulatory Affairs - Basic Course at ZWW/Augsburg University

The part-time certificate course “Drug Regulatory Affairs – Basic Course” will again take place at the Centre for Continuing Education and Knowledge Transfer (ZWW) at Augsburg University from 12 to 28 September 2019. The course is addressed to both young professionals and specialists and managers from the pharmaceutical industry and related areas.

The course will not only provide basic knowledge of pharmaceutical law but also addressing topics that go beyond purely legal aspects. Oriented towards the legal product cycle, the individual stages from the product idea to the successful marketing of medicinal products, including relevant compliance topics, will be conveyed in a compact and practical manner. Lecturers of the certificate course are proven experts in pharmaceutical law from Augsburg University, the legal profession, industry, associations and health insurance funds.

Dr. Ina Gerstberger will again give a lecture in Module I – Fundamentals of Pharmaceutical Law on the topic “Product delimitation” of medicinal products from foodstuffs, cosmetics and medical devices. Further information on the certificate course and registration can be found here: http://www.zww.uni-augsburg.de/fuer-fach-und-fuehrungskraeftesie-kommen-zu-uns/juristische-weiterbildung/drug-regulatory-affairs/

 

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New legislation on transparency and sustainability of the EU risk assessment model in the food chain

On 13 June 2019 the Council adopted the new EU Regulation on transparency and sustainability of EU risk assessment model in the food chain, which is expected to enter into force at the end of September and will apply 18 months later, i.e. by end of March 2021.

What’s at issue ? 

This new Regulation will amend Regulation (EU) 178/2002 on general food law and also eight sectoral acts applicable in certain sectors of the food chain:

  • Genetically modified organisms (cultivation and use in food/feed)
  • Feed additives,
  • Smoke flavouring,
  • Food contact materials,
  • Food additives,
  • Food enzymes and flavourings,
  • Plant protection products and
  • Novel food

Objectives of the new EU Transparency Regulation 

The new Regulation is the response to the successful European Citizens’ Initiative on “Banning glyphosate and toxic pesticides” and builds upon the results of the January 2018 fitness check of the General Food Law Regulation.

It aims at

  • increasing the transparency of the EU risk assessment in the food chain,
  • on strengthening the reliability, objectivity and independence of the studies used by European Food Safety Authority (EFSA), and
  • revisiting the governance of EFSA in order to ensure its long-term sustainability.

How will the objectives be implemented? 

All studies and information supporting a request for a scientific output by EFSA are to be made public automatically when an application is validated or found admissible. This will be done:

  • at the very early stage of the risk assessment process, and
  • in an easily accessible electronic format with the possibility to search, download and print the studies.

Confidential information will be protected in duly justified circumstances, among others in relation to:

  • the manufacturing or production process, including the process and its innovative aspects, and other technical and operational specifications for that process, with the exception of such information relevant for the safety assessment;
  • business relations between a manufacturer or importer and the applicant or marketing authorisation holder;
  • commercial information from which the sources of supply, market shares or the business strategy of the applicant emerge plus the quantitative composition of the subject matter of the request, however again with the exception of such information relevant to the safety assessment.

Confidentiality claims will be assessed by EFSA.

Other measures which will also ensure a more robust, independent and transparent risk assessment process are:

  • A notification obligation for applicants and laboratories when studies are commissioned and creation of a database of commissioned studies: This will provide a mechanism by which EFSA will be able to double-check whether all studies commissioned by an applicant in the context of its application for an authorisation, have been submitted;
  • Consultation of stakeholders and of the general public on submitted studies to ensure EFSA’s comprehensive access to existing evidence underpinning its risk assessment;
  • A specific procedure, including consultation of stakeholders and the general public on planned studies in the case of renewals of already authorised substances;  
  • Pre-submission advice on the applicable rules and the required content of an application dossier, to be provided by EFSA upon request to potential applicants;
  • Fact-finding missions by the Commission to ensure the compliance of laboratories/studies with standards; 
  • Possibility for the Commission to ask EFSA to commission studies in exceptional circumstances to verify evidence used in its risk assessment process.

Another plus: Comprehensive risk communication

Another core element of the new EU-Transparency Regulation is to ensure a coherent communication throughout the risk assessment process.

To this end, the new Regulation sets out objectives and general principles of risk communication. Based on these objectives and general principles, the Commission is empowered to set out a general plan on risk communication by means of an implementing act, to promote an integrated risk communication framework for all risk assessors and risk managers on all matters relating to the food chain.

The general plan on risk communication should:

  • identify the key factors to be taken into account when considering the type and level of risk communication activities needed, (e.g. different level of risks, nature of risk, risk perceptions etc.);
  • determine the tools and channels to be used as well as the appropriate mechanisms of coordination and cooperation between the risk assessors and risk mangers; and,
  • launch an open dialogue amongst all interested parties.

More detailed information on the new Regulation will follow once it has been published in the Official Gazette.

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