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Mar 28 2014 8:00AM - Mar 28 2014 5:30PM | NH Danube City
Wagramer Strasse 21
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.
During the Information Day, an update will be given both on status of active topics, new topics and ICH reforms regarding transparency, membership, governance and future funding.
Professionals in regulatory affairs, regulatory submissions, pharmacovigilance, toxicology and quality assurance / quality control from industry and drug regulatory authorities, who want to be updated on the future of ICH and the status of active ICH topics.
At the conclusion of this Information Day, participants should be able to:
REGISTER 3 AND GET THE 4TH FREE!
All four individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already discounted fees for government or charitable non-profit/academia offerings. To take advantage of this offer, please make a copy of the registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to email@example.com.
Printable Registration Form
The Information Day will take place at:
Hotel NH Danube City
Wagramer Strasse 21
1220 Vienna, Austria
Tel.: +43 1 260 200
Tel.: +41 61 225 51 51Fax: +41 61 225 51 52Email: firstname.lastname@example.org
EFPIA Member ICH Steering Committee, Sr Vice President Medicine & RegulatoryBoehringer Ingelheim Pharmaceuticals, United States
EFPIA ICH Coordinator, Director Regulatory AffairsEFPIA, Belgium
Scientific DirectorJanssen Research & Development, Belgium
In 2012, building on 20 years of successful collaboration towards achieving greater international harmonisation for pharmaceutical products registration, the six official ICH parties have agreed on new principles of governance which better define the role of the regulator and industry parties within ICH, and also confirmed their commitment to strengthen ICH's global outreach.
In June 2013, these new principles were integrated into the ICH Procedures document and applied to the ICH harmonisation process. At the same time, the Steering Committee agreed measures aimed at further increased transparency such as the publication on the ICH public website of: the entire ICH Procedures document, the working plans for each ongoing technical topic and the decisions taken at the SC meetings.
This session aims to present the main changes in the revised ICH Procedures and also to provide you an overview of recent progress made towards ICH increased transparency. Information will also be given on recent development and governance of MedDRA.
The session will give the background to initiatives from the EU to reform ICH and from EFPIA to develop new ICH topics. An update on what has been agreed so far and information on ongoing discussions on the future of ICH will be also given.
Growing needs for efficient handling of regulatory information require innovative electronic standards. Ten years after the successful introduction of eCTD v3.2.2 the M8 Expert Working Group (EWG) is currently working on the next major version of eCTD introducing v4.0 as a versatile exchange standard for electronic regulated product submissions. The M2 EWG provides in this context the framework for the development of new electronic ICH standards involving Standards Developing Organisations (SDOs). In parallel M2 currently evaluates, under its original mandate, future document standards for regulatory information addressing requirements for more structured information. Latest Pharmacovigilance activities include the preparation of a Q&A regarding the implementation and technical maintenance of the “Periodic Benefit / Risk Evaluation Report”, which the E2C(R2) Implementation Working Group (IWG) worked on after successfully reaching Step 4 in May 2013.
This session aims to provide information regarding a number of (evolving) ICH Safety and Quality guidelines. The presented spectrum ranges from more specific Safety (ICH S10, photosafety) and Quality (ICH Q7, GMP) topics to a clear area of overlap between Safety and Quality: impurity management (ICH Q3D, elemental impurities and ICH M7, DNA reactive impurities).
Especially in the area of impurity management the last decade has provided a series of guidance documents to industry ranging from mutagenic impurities to metal catalysts. Although it is obvious that the common goal is to guarantee patient safety and quality of the products, the ever increasing challenge for industry and regulators is to strike a balance between perceived risks, (technical) capabilities and various guidelines.