pharmacovigilance audit / inspection workshop

Day Two
15% discount for students
Registration fees include workshop materials,
attendance certificate, refreshment services &
lunch.
Session IV: PV Technical Requirements
•
•
09:15-09:45 EU & US: Pre & Post-marketing
requirements. Dr. Reem Al-Essa. Pharmaceutical
Regulatory Affairs Researcher
Payment Method
09:50-10:45 Pharmacovigilance Inspection: Legal,
technical & scientific context as well as structure &
procedures involved in the respective process. Dr.
Amr Saad, Head of Pharmacovigilance Centre, Egypt.
10:50-11:30 Pharmacovigilance and risk management
plans: receiving, collecting, analysing and managing
signals. How to report signals to the regulatory authorities?
Pharm Ahmed Saeed, DRA Manager, Sandoz, Kuwait
11:35-11:55 Questions
12:00-12:25 Prayers & Refreshments
Session V: Breakout Session II
12:30-13:30 Managing ICSRs & PSURs: What
type of ICSR to be submitted? How to prepare,
& evaluate PSUR? What are the submission
timelines for PSURs according to the Arab PV
guidelines?
13:50-14:10 Workshop Remarks
14:15-14:25 Workshop Conclusion
Cash/Debt

Card: write to us to find out your
applicable discount rate
Credit

Card: write to us to find out your applicable
discount rate
Cheque

made payable to Kuwait Advancement for
conference & Exhibition Management FDN
Bank

transfer the registration fee directly to the
following bank account:
o
Account Name: Kuwait Advancement for Conference
& Exhibition Management FDN
o
Account number: 401010006526
o
IBAN: KW38KFHO 0000 0000 0040 1010 006526
Payment confirmation notifications will be sent to
your email address, once your payment is processed
successfully.
Refund policy: Registrants who cannot attend & do not
send a substitute are liable for full refund if a request
is received in writing 7 days before the workshop
commencement date.
14:30 Lunch
END OF WORKSHOP
Registration Process/ Query
•
•
•
Fill-up the registration form & send it to
[email protected] or [email protected]
or deliver it to Shuweikh, Journalism Street,
Airport Rd, Al-Resala Building, First Floor
Write to [email protected] for any query
or Call +954 24915584/5 or
Fax +965 24915583
Refer to www.kadcem.com to download the
brochure.
Registration fees
280 KD for individuals
The following discount offers are provided up to the
9th February 2015:
• Group Discounts (10% for group of 3-5, 12% for
a group of 6 or more)
• 12% discount for government officials & academics
Registration Form
PV Audit/Inspection Workshop
18-19 Feb 2015
PHARMACOVIGILANCE
AUDIT / INSPECTION
WORKSHOP
Decision made with confidence
18 - 19 February 2015
Al-Beda - Kuwait
Workshop Moderator
Pharm. Donia Bastaki
Head of Registration Department
Kuwait Drug and Food Control
Ministry of Health, Kuwait
Keynote Speaker
Guest Speaker
Name: ……………………………................………………………………….
Job Title: …………………………………………..............…………………
Organisation: …………………………………............…………………..
Registration fee: …………………………………...........………………
Form of Pay: …………………………………………............……………
Tel: …………….......….……………Fax: ………………….......……………
Mobile: ……………….......……Email: ………....………………………
Date: ……………..…….......………. Sign: …...........…………………….
Dr. Amr Saad
Head of Pharmacovigilance
Centre, Egypt
Pharm. Ahmed Saeed
DRA Manager
Sandoz, Kuwait
ORGANISED BY:
KUWAIT ADVANCEMENT FOR CONFERENCE &
EXHIBITION MANAGEMENT FDN.
(KADCEM)
Pharmacovigilance
Audit/Inspection Workshop
Background
The history of drug withdrawals is filled with public
& press attention directed towards people who were
harmed by the adverse drug reactions. Such attention,
however, has moved to documenting the frequency of
adverse events & means for managing them effectively.
International regulatory guidelines on pharmacovigilance
(PV) & risk management plans are increasing. Companies
are now turning their efforts towards auditing their premarketing & post-marketing safety monitoring practices
to ensure that they comply with Good Pharmacovigilance
Practices (GPvP).
PV audit/inspection processes are based on a robust
approach that embraces key PV principles required
in every regulatory authority & pharmaceutical
company. It lines up a company’s procedures with
the regulatory authorities’ increasing demands for
solid safety monitoring systems. Every PV function
will experience governmental or health authority
inspections as well as audits by license partners,
internal auditors & others.
Therefore, this workshop was designed to address the
need for optimum PV systems & processes that meet
regulatory expectations in any operating PV function.
It will concentrate on the criteria & methods of
preparation for a PV audit / inspection from the time
of the receipt of the notice to the final conclusion of
the audit or inspection procedure.
Workshop topics

PV regulations in EU, & USA.

Pharmacovigilance in Arab Countries.

The difference between audit & inspection

Preparing for an Audit/inspection

Best Practices in conducting an effective PV system

Meeting Safety Requirements as per Arab PV Guidelines
Why should people attend?
Session I: Introductory session
•The increasing demand for PV systems as a response
to global rise in drug development, approval & use.
•There is a growing need for the development of
effective risk minimization strategies
•Any operating PV unit needs to understand the
requirements for getting ready for a PV audit/
inspection
•It is important to understand how to handle Adverse
Event reporting in post-marketing surveillance
studies
•Attending the workshop is crucial for those who are
eager to discuss controversial topics in a plausible &
explicable manner
09:30-10:00 Ensuring quality within the PV Process.
Dr. Reem Al-Essa. Pharmaceutical Regulatory Affairs
Researcher
Who should attend?
11:15-11:45 QPPV training & preparing a successful PV
& risk management plan for products to be submitted
as per GCC guidelines. Pharm. Ahmed Saeed, DRA
Manager, Sandoz, Kuwait
This workshop program is ideal for:

Healthcare Professionals (Doctors, Nurses,
Pharmacists)

Regulatory Affairs Professionals

Pharmacovigilance Specialists

Individuals from healthcare industry or academia

Medical & Pharmaceutical Associations

Students & researchers from various fields of life
sciences, medical sciences & pharmaceutical sciences.
Invited Speakers
Dr. Amr Saad
Head of The Egyptian pharmacovigilance Centre
(EPVC), Egypt
Pharmacist Ahmed Saeed
DRA Manager, Sandoz, Kuwait
10:05-10:25 The difference between PV Audit & PV
Inspection, Dr. Amr Saad, Head of Pharmacovigilance
Centre, Egypt
Session II: The PV Audit/Inspection
Process I
10:30-11:10 PV Inspection from the Regulatory
Perspectives: Operation of the PV inspection process
according to Arab PV Guidelines. Dr. Amr Saad, Head
of Pharmacovigilance Centre, Egypt
11:50-12:00 Questions
12:05-12:25 Prayers & Refreshments
Session III: The PV Audit/Inspection Process II
12:30-13:25 PV Audit process: How to ensure that
a company (or its affiliates & partners) is complying
with the Arab PV guidelines. Dr. Amr Saad, Head of
Pharmacovigilance Centre, Egypt
Session IV:
Breakout Session I
13:30-14:25 Group work discussing scope &
plan of pharmacovigilance
audit/inspection
14:35-14:45 Conclusion
Workshop Program
Moderated by Pharm. Donia Bastaki
Head of Registration Department, Kuwait Drug &
Food Control, Ministry of Health, Kuwait
Day One
Opening Ceremony
09:15-09:25 Opening Speech
Dr. Reem Al-Essa. Executive Director at Kuwait
Advancement for Conference & Exhibition
Management FDN
15:00 Lunch

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