Advanced Veterinary Pharmacovigilance (London, United Kingdom - October 2-3, 2018)

  • ID: 4435273
  • Conference
  • Location: London, United Kingdom
  • 2 Days
  • Management Forum
  • Conference Dates: October 2-3, 2018
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Volume IXb is the new key document on Pharmacovigilance guidelines used by the Veterinary regulatory authorities. The purpose of this course is to provide a comprehensive, yet practical assessment of the main requirements to ensure a compliant reporting Company. It will also consider the implications of the proposed EU Regulation for Veterinary Medicinal Products and its impact on pharmacovigilance.

Why you should attend

PROGRAMME TO INCLUDE

  • Overview of European regulatory framework
  • PV Training
  • Product Safety Review
  • Company Core Safety Information
  • Compliance and PV
  • PV Reporting in Licensing/Distribution Agreements
  • Signal Detection
  • Benefit-Risk Assessments
  • Risk Management
  • Crisis Management
  • Implications of the proposed EU Pharmacovigilance legislation

Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.

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Programme Day One

09.00 Registration and Coffee

09.30 Welcome and Introductions

The DDPS and the PV Master File

  • The DDPS
  • The DDPS – What happens now
  • The PV Master File – purpose and maintenance
  • Transition from DDPS to PV Master File

PV Training

  • Requirements for PV training
  • Who trains whom and when?
  • Training records, maintenance and updates
  • Role of QA and HR in training

Product Safety Reviews

  • The Safety Review Committee
  • Timings for Safety Review
  • Record keeping for Safety Review meetings

Company Core Safety Information

  • Core Safety Information
  • How to determine what to include, what to exclude in CSDS
  • Maintenance & development of CSDS

Compliance and PV

  • Basic principles
  • Measuring compliance
  • Quality versus quantity in safety reports

17.00 End of Day One

Programme Day Two

09.00 PV Reporting in Licensing/Distribution Agreements

  • What types of Agreements exist?
  • Audits of pharmacovigilance capabilities in partners
  • What agreements need to be in place for PV reporting?
  • PV reporting agreements – what needs to be covered?
  • Monitoring PV agreements – what happens if it goes wrong?

Signal Detection/Benefit Risk & Risk Management

  • The pharmacovigilance system - Signal Detection and Analysis: What is required?
  • Benefit-Risk assessments
  • Risk management/minimisation
  • Crisis Management
  • Communication with the Public

Audits & Inspections: Are you Ready?

What are inspectors looking for?

  • Inspection findings and outcomes

Discussion will take place throughout the two days

16.30 End of Day Two

Programme Day Two

09.00 PV Reporting in Licensing/Distribution Agreements

  • What types of Agreements exist?
  • Audits of pharmacovigilance capabilities in partners
  • What agreements need to be in place for PV reporting?
  • PV reporting agreements – what needs to be covered?
  • Monitoring PV agreements – what happens if it goes wrong?

Signal Detection/Benefit Risk & Risk Management

  • The pharmacovigilance system - Signal Detection and Analysis: What is required?
  • Benefit-Risk assessments
  • Risk management/minimisation
  • Crisis Management
  • Communication with the Public

Audits & Inspections: Are you Ready?

What are inspectors looking for?

  • Inspection findings and outcomes

Discussion will take place throughout the two days

16.30 End of Day Two

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  • Declan O'Rourke Mr Declan O'Rourke,
    Director ,
    Ortec Consultancy


    Declan O’Rourke has over 20 years’ experience in industry where he has held technical, marketing, product development, clinical development, production and pharmacovigilance roles.

    He is a Veterinary surgeon, holds a Diploma in Marketing, a Master of Business Administration and a Fellowship of the Royal College of Veterinary Surgeons. He now directs Ortec Consultancy specialising in EU pharmacovigilance and represented IFAH-EU in the VICH Working Group on pharmacovigilance.

    He is Associate Professor in Veterinary Pharmaceutical Development at Nottingham Veterinary School, Senior President of British Cattle Veterinary Association and a member of the Veterinary Residues Committee and the Veterinary Products Committee (VPC).

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This course will be beneficial to those who have some experience of Veterinary Pharmacovigilance and is a good follow-on course from the Introduction to Veterinary Pharmacovigilance course run by Management Forum. Adverse event monitoring and drug safety offices together with regulatory affairs and personnel from registration departments will find this seminar useful.

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ADDRESS

Rembrandt Hotel
11 Thurloe Pl,
Kensington
London
SW7 2RS
United Kingdom


DIRECTIONS

The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.

You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.

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