CHCUK

November 2013
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In this Month's Issue
CHCUK: NIS Considerations (Europe)
CHCUK: NIS Training - Try Before You Buy
CHCUK: Late Stage Submissions Plan (LSSP).
CHCUK Ltd: New Company Name
EFPIA: New Code of Practice
France: Disclosure of Agreements with and Advantages to Healthcare Professionals
Poland: Belatedly Implements Directive 2010/84/EU
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compliance
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Introduction to NIS eLearning
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NIS Country-specific eLearning

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Country-Specific NIS Reports
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Summary of NIS Requirements for Europe
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CHCUK: Free NIS Resources


As we draw near the end of another year, we continue to see significant changes in the field of non-interventional studies. Indeed, we're all still evolving our systems and processes to accommodate the requirements of the EU Pharmacovigilance legislation.

List will be the last of the 'lengthy' newsletters.  We're updating our websites so that the details of the bimonthly updates will be included on our website.  The NIS Considerations newsletter will provide a few sentences per article.  If you want to read more, then you will just need to click the 'read more' link and you'll be directed to our updated website.

I hope you'll find the following information and resources useful.
News


Best wishes,

Stuart McCully
CHCUK
 
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510
email: stuart.mccully@chcuk.co.uk
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CHCUK: NIS Considerations (Europe - Part 2)
It's Coming: Part 2 of our NIS Considerations Europe Report

null "Where's my update to Part 2 of the NIS Europe Report?!"

It's a very good question.  We were hoping to publish the 3rd Edition of the Report at the same time as our new website was released.  However, a combination of factors has resulted in a delay of the website and report.  Such is life!

The 2013 version of Part 2 of our NIS Considerations - Europe report will be released in December 2013.

If you have previously purchased  the report you will receive a complimentary copy.  If you haven't received a copy by 1st February 2014 then please email me and I'll ensure you receive your copy

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CHCUK: NIS Training - Try Before You Buy
The NIS Considerations - UK eLearning Module is now Free 
 

Rather than try to convince you of the worth of our NIS country-specific eLearning modules, we've decided to show you.

You can now access the NIS country-specific considerations elearning module for the UK, free of charge (normal cost = 100).  This way you can 'test the waters' for yourself and 'try before you buy'.

If you're interested, just follow the link:
CHCUK: Late Stage Submissions Plan (LSSP)

Are you up to speed with the country-specific regulatory requirements and considerations for your study?  
Checklist
The regulatory considerations for non-interventional studies are complicated by the fact that each country has it's own classification, notification and approval requirements.

Stand-Alone NIS Regulatory Services
We address this challenge by developing a Late Stage Submissions Plan for each study we support.  The support provided can either be as stand-alone regulatory services or as a full service provider, thanks to our strategic partnership with the Late Stage Division of inVentiv Health Clinical

 

Study-Specific Late Stage Submission Plan (LSSP) 

This is a key tool in ensuring compliance with the regulatory requirements for the planning, conduct and reporting of non-interventional studies.

 

Furthermore, the LSSP provides project team members, including affiliates, with up-to-date, detailed and accurate information on the country-specific requirements and considerations for that particular non-interventional study. 

 

If you would like to know more about our Late Stage Submission Plans, or would like to receive a redacted example then please email me at:

 


stuart.mccully@chcuk.co.uk or stuart.mccully@inventivhealth.com

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CHCUK Ltd: New Company Name
We've Changed our Company Name 

TIn order to being able to fit the company name on our business cards we are now called 'CHCUK Ltd' rather than 'Compliance Healthcheck Consulting UK Ltd' 

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EFPIA: New Code of Practice
Reminder  - 2013 EFPIA COP to be Implemented in National Codes by 31 December 2013  
EFPIA

This is a reminder that the EFPIA Code on the Promotion of Prescritopn-Only Medicines to, and Interactions with, Healthcare Professionals (EFPIA COP) was updated on the 24 June 2013.

National codes therefore need to be by 31 December 2013, which means that 2014 will see a change in all national codes to reflect the revisions.

Revisions to the EFPIA COP include:

Amendment to Article 10 (previously Article 9) on Events & Hospitality, Article 17 (previously Article 10) on Gifts, and introducing a new Article 9 on Informational & Educational Materials, and Items of Medical Utility

For more information refer to the 2013 EFPIA COP

 

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France: Disclosure of Agreements with and Advantages to Healthcare Professionals
Have you Notified CNOM of Any Agreements with Healthcare Professionals?  

REMINDER - In June 2013 we informed you of new disclosure requirements which were implemented by Decree No. 2013- 414 dated 21 May 2013 lays down the implementation provisions of Article L.1453-1 of the CSP. These new provisions will come into effect on 1st June 2013. At this date, the companies will have to disclose all the agreements signed and advantages granted in 2012.
 
According to the provisions of new article L.1453-1 CSP, pharmaceutical companies must now disclose the existence of agreements that they concluded with:
 
  • Healthcare professionals,
  • Associations of healthcare professionals,
  • Students in medicine and odontology,
  • Associations of patients,
  • Health establishments,
  • Foundations,
  • Press organs for health professionals for all media (press, radio, TV or online communication);
  • Medical prescription and deliverance software editors;
  • Learned societies.
 
Each company must disclose the information for each agreement concluded.
 
Above a limit of 10 euros all taxes includes, the obligation of disclosure also applies to the advantages in nature or in money granted directly or indirectly by pharmaceutical companies to the above listed recipients. Consequently, all advantages granted to persons listed above that are above 10 euros will have to be disclosed.
 
The said information will be disclosed in French on a unique public website held by an authority to be created by an order of the Ministry of Health.
 
The companies will have to transmit the above-mentioned information to this authority within 15 days from the execution of the agreement and at least on 1st August of each year for the advantages granted during the 1st semester of the year and at least on 1st February of each year for the advantages granted during the 2nd semester.
 
The authority must then disclose the information on the website for the 1st semester of the year on 1st October and for the 2nd semester on 1st April.
 
Before the establishment of the relevant authority, a transitional period is put in place. For the time being, the information will be disclosed on the website of the relevant professional society of the healthcare professional (if a physician, on the website of the Medical Doctor Society) or on the website of the company if no relevant professional society exists. A professional syndicate may also take the responsibility to disclose this information for its members.
 
Regarding the agreements concluded and the advantages granted in 2012, the companies have to transmit all relevant information before 1st June 2013. The information shall be made available on the website of the professional societies, of the professional syndicates or of the companies at least on 1st October 2013.

This CNOM procedure is described on the CNOM website:
Acknowledgements:
  • Paule Drouault-Gardrat and Juliette Peterka, PDG Avocats
  • Benedicte Bonnet, Senior CN CRA, inVentiv Health Clinical 
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Poland: Belatedly Implements Directive 2010/84/EU
Act of 27 September 2013 Belatedly Implements the EU Pharmacovigilance Directive

On 25 November 2013, the Act of 27 September 2013 on the change of the Act - Pharmaceutical Law and some other acts (Journal of Laws of 2013, item 1245) came into force.

The modified system, which belatedly implements an EU pharmacovigilance directive, is intended to be more effective than the current system and contain stronger links to the EU system.

Key changes include:
  • improving information-collecting procedures about suspected adverse reactions to medicinal products
  • widening the definition of adverse reaction to allow more comprehensive data to be collected. The new definition will include harmful and unintended effects arising from the unauthorised use of pharmaceuticals, such as overdosing, medical errors, and off-label use
  • introducing a clearer division and more detailed specification of the duties of regulatory authorities and marketing authorisation holders to collect and assess information about suspected adverse reactions to pharmaceuticals and to cooperate with the European Medicines Agency
  • entitling patients to report adverse reactions directly to marketing authorisation holders, or to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  • introducing new obligations, where there are safety concerns about a pharmaceutical product, so that marketing authorisation is only granted subject to the holder conducting post-authorisation safety and efficacy studies, and complying with stricter obligations on the recording or reporting of suspected adverse reactions than those provided by the new law

Law:

Acknowledgements: Monika Duszynska and Bartosz Michalski, cms-cmck.com 

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