VARIATIONS TO MARKETING AUTHORISATIONS IN THE EU

VARIATIONS TO MARKETING
AUTHORISATIONS in the EU
5 March 2015, Conf. No A3-1015
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VARIATIONS TO
MARKETING
AUTHORISATIONS
IN
THE EU
Review of the Variations Regulations
W
Dates
5 March 2015
Start: 09.30 – Finish: 17.00
Registra
tio
Informati n
on
Registration & Coffee
5 March 2015 09.00
Venue and Accommodation
The Rembrandt Hotel, 11 Thurloe Place,
London SW7 2RS
Hotel Tel: +44(0)20 7589 8100.
Hotel Fax:+44(0)20 7225 3476.
Email: reservations_rembrandt@sarova.co.uk
Subject to availability, a limited number of
bedrooms have been reserved at the hotel at a
special rate.
Update on Mutual Recognition/Decentralised, Centralised
and National Variations (with emphasis on UK and Ireland)
Topics covered at this seminar:
All bookings should be made directly with the
hotel or online at www.sarova.com/rembrandt,
quoting promo code ‘manforum’.
Directions
Opposite V&A Museum.
Nearest underground station: South Kensington.
www.sarova-rembrandthotel.com/location-local-attractions
Fee
£575 + VAT if applicable. The fee includes
course documentation as well as mid-session
refreshments and lunch. Invoice and confirmation
will be forwarded to you.
Register
online at
www.managementforum.co.uk
or telephone
+44 (0)1483
730071
Conference No. A3-1015
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registrations@management-forum.co.uk
Tel: +44 (0) 1483 730071
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Fax: +44 (0) 1483 730008
To
Re
gi
JOIN US ON
introduction to the EC system for Variations with
An
practical advice on the preparation and submission
of Variation applications using the various European
procedures
n The Current Variations Regulations of the
European Commission and procedures in
practice
n Review of latest requirements
n Biologicals and Biotech
n Pharmaceutical Variations
n Clinical Variations
n The Variations: how have they changed in
practice (workshop)
Chairman:
Dr Patrick Salmon
st
er
if you have NOT received confirmation seven
days after registering please contact
registrations@management-forum.co.uk
Discounted Rates
Available on application for personnel from non-profit
making organisations and registered charities.
Group discount available on request
If you do not want to receive future mailings from Management Forum please contact nick@management-forum.co.uk
If you do not wish to receive selected third party mailings please contact nick@management-forum.co.uk
Senior Medical Officer, HPRA
Speaker:
Dr Anmar Marouf
Senior Consultant
Pharmaceutical Consultant, PAREXEL International, Germany
5 March 2015
The Rembrandt Hotel, London
OBJECTIVE
CHAIRMAN
This meeting will give an introduction of
the EC system for Variations with practical
advice on the preparation and submission
of Variation applications using the various
European procedures.
Dr Patrick Salmon is Senior Medical
Officer, HPRA. He has worked for many
years reviewing all types of application
including national, mutual recognition,
decentralised and centralised applications.
He is one of the Irish CPMP delegates and
Chairman of the ad hoc group on SmPC.
He is the Irish alternate CHMP member and
Chair of the SmPC group on harmonisation.
There will be a review of experience with
the latest Variation Regulations and of the
available guidance on how they are being
implemented.
WHO SHOULD ATTEND
The meeting is addressed to clinical
and pharmaceutical personnel in
the registration and regulatory
affairs departments of the
pharmaceutical industry, and all those
involved in regulatory strategy for
submissions to European markets.
ATTENDANCE LIMITED TO
30 - EARLY REGISTRATION
RECOMMENDED
This limitation, a unique feature of all
MANAGEMENT FORUM seminars, will
give participants the opportunity for a
thorough discussion of the complex issues
to be covered by the programme.
FORTHCOMING EVENTS
For a full list of forthcoming conferences
and seminars please visit our website at: www.management-forum.co.uk You may
make a registration and request a brochure
on-line.
He previously worked as Medical Director
in a CRO and then in the Irish office of
a large international pharmaceutical
company.
SPEAKER
Dr Anmar Marouf has over 10 years of
hands-on experience in the pharmaceutical
industry and CMC/Quality consulting
and writing. As project lead and subject
matter expert, he is currently coordinating
and supervising various CMC/Quality
related projects primarily within European
centralised and decentralised procedures.
He is an expert in the preparation, review
and gap analysis of CMC/Quality
documentation (CTD Modules 3 and 2.3,
IMPDs), expert’s reports and applicant’s
response documents.
09.30uThe Current Variations Regulations of the
European Commission and procedures in Practice
• Types of Variation
• How to submit a Variation
• Procedural and Practical Guidance
• Processing timescales
Dr Patrick Salmon
11.00uCoffee
11.15uThe Variations Regulations: the guidance
• Examples of current experience
• Common reasons for invalid applications
Dr Anmar Marouf
12.30uLunch
13.45uVariations Workshop
(Classification and Grouping)
15.15uTea
15.30uClinical Variations
His experience in the pharmaceutical
industry includes the manufacturing,
packaging, technology transfer, validation,
qualification and SOPs/documentation for
pharmaceutical products of major
pharmaceutical companies.
• New indications
• Extension of products into new patient groups
• Supporting data and Expert Reports, including requirements for generic products
• Amendments to safety information
Dr Patrick Salmon
Dr. Marouf holds a PhD in Pharmaceutical
Technology from the University of Freiburg,
Germany.
16.15uPharmaceutical Variations (chemicals, biologicals and biotech)
DOCUMENTATION
Participants will receive a course material
folder containing comprehensive
documentation provided by the speakers,
which will be a valuable source of
reference for the future.
Programme
A Certificate of Attendance for
Professional Development will
be given to each participant who
completes the course
• Variations involving the submission of European Pharmacopoeia Certificates of Suitability
• Type II Variations versus Line Extensions
• Drug Master Files
• Quality Overall Summaries (Expert Reports)
Dr Anmar Marouf
17.00uEnd of meeting