Press Releases – Julphar

Introduction

Pharmacovigilance (PV) is defined by the World Health Organisation (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Monitoring the safety of medicines includes all activities related to the detection, assessment, understanding and prevention of adverse effects and other possible drug-related problems. This monitoring is carried out in a number of ways, including review and evaluation of suspected adverse reaction reports, published literature, epidemiological studies and additional clinical trial results.

Julphar continually assesses new and emerging safety data as it becomes available and undertakes regulatory action as appropriate. In addition to contributing to the safety profiles of existing drugs, pharmacovigilance activities help to improve the knowledge set and contribute to the breadth of epidemiological data.

Pharmacovigilance is therefore vital for the advancement of medical understanding, future research and product development. Any improvements in safety or understanding will ultimately lead to improvements in patient care.

Julphar’s Responsibility

Julphar is responsible for reporting suspected adverse reactions to the authorities of each country for medical products received from Health Care Professionals (HCP) (including but not limited to medical doctors, pharmacists, nurses, dentists, allied health professionals, midwives, caregivers etc.).

All queries and product related complaints are taken very seriously and treated with the strictest confidentiality. All employees of Julphar participating in the pharmacovigilance activities are trained, know their responsibility and are able to execute their duties.

As per Julphar policy, all employees are required to report any issues relating to the safety or quality of our medicines immediately. All spontaneous adverse events of marketed products are collected via phone, email, fax or post. All adverse events of investigational products are collected as per the Clinical Trial Protocol via above mentioned means.

What about expedited reporting?

Julphar will transmit all Individual Case Safety Reports (ICSRs) requiring expedited reporting promptly and no later than 15 calendar days from receipt. This applies to initial and follow-up information.

The clock for expedited reporting starts as soon as one or more of the following has received the minimum information (an identifiable patient, an identifiable reporter, a suspected reaction, and a suspected drug) required for the submission of an adverse reaction report:

Any personnel of Julphar – including sales representatives.
The Qualified Person responsible for Pharmacovigilance (QPPV) or persons working for or with this person.
Where Julphar has entered into relationships with a second company for the marketing of, or research on, the suspected product, the clock starts as soon as any personnel of Julphar receives the minimum information. However, wherever possible, the time frame for regulatory submission should be no longer than 15 calendar days from first receipt by the second company and explicit procedures and detailed agreements will exist between Julphar and the second company to facilitate achievement of this objective.
In the case of relevant world-wide scientific literature, the clock starts with awareness of the publication by any personnel of Julphar; Julphar will maintain awareness of possible publications by accessing a widely used systematic literature review and reference database, no less frequently than once a week, or by making formal contractual arrangements with a second party to perform this task; Julphar will also ensure that relevant publications are appropriately reviewed.
Expedited reporting of serious adverse reaction will be reported as soon as possible, but in no case later than 24 hours of initial receipt of information by the healthcare provider.

What should I do if I think I may have experienced an adverse reaction (side effect)?

Julphar encourages patients, carers and other members of the public to report suspected adverse reactions (side effects) to us. It is important that you also contact your doctor or pharmacist if you think you may have experienced a side effect after using a medicine.

They will tell you if you need any medical care. They will also consider if you need to change your treatment or if you need a different treatment. Most of us will not experience any problems when using medicines. However, all medicines have some risks associated with their use and so a small number of people may experience an adverse reaction (also known as a side effect).

If you are concerned that you have had a suspected adverse reaction to a medicine, you may need to contact your healthcare professional who can advise on any treatment that may be needed. They can also report the issue to Julphar on your behalf.

If you wish to directly report an adverse reaction you can use Julphar’s online reporting service. Anyone can report issues relating to the safety of medicines to Julphar. This includes patients, carers, other members of the public and healthcare professionals.

What should I do if I think I may have experienced an adverse reaction (side effect)?

Contact Information

Global Pharmacovigilance Contact Information

You can report a suspected side effect in a number of ways:

To your doctor, pharmacist or nurse who can then notify Julphar.
By using our online form.
By phone or fax:
Toll Free: 800-4994 (available 24 hours).

Direct: +971 7 2045439

Fax:

In person/by post: Medical Affairs Department, Pharmacovigilance Unit, Digdaga, Ras Al Khaimah, UAE, PO Box 997.
By email: medical.affairs@julphar.net.

Country Wise Pharmacovigilance Contact Information

Egypt

Name: Nadia El-Desouky

Title: Local safety responsible

Mobile: +201147111948

Telephone: 20222728980

Fax: 20222728981

Email ID: nadia.eldesouky@julphar.net

Address: 57 Mostafa El Nahas St. Nasr City – Cairo - Egypt

Name: Mayar Khaled

Title: Deputy Local safety responsible

Mobile: +201022930074

Telephone: 20222728980

Fax: 20222728981

Email ID: mayar.fattah@julphar.net

Address: 57 Mostafa El Nahas St. Nasr City – Cairo - Egypt

Ethiopia

Name: Sara Tadesse

Title: Local safety responsible

Mobile: +251942858540

Telephone:

Fax:

Email ID: sara.tadesse@julphar.net

Address: Summit,Lemi kura subcity,Addis Ababa.

Jordan

Name: Areej Damra

Title: Local safety responsible

Mobile: 00962799642741

Telephone: 009625868823

Fax: 0096256868821

Email ID: areej.d@pds.jo

Address: Amman-Abdullah Ghosheh Str.,Alra`fa Center-No.58 P.O.Box 3512-Amman 11953 Jordan

Name: Dania Saleh

Title: Deputy Local safety responsible

Mobile: 00962791042080

Telephone: 009625868821

Fax: 009625868823

Email ID: dania.s@pds.jo

Address: Amman-Abdullah Ghosheh Str.,Alra`fa Center-No.58 P.O.Box 3512-Amman 11953 Jordan

KSA

Name: Sara abuhaimed

Title: Qualified person for pharmacovigilance

Mobile: +966547540820

Telephone: 00114631299

Fax: N/A

Email ID: sara.abuhaimed@julphar.net

Address: SALAH ADEEN ST. AL BAIT BLDG NO.1 First Floor: OFFICE NO.-1

Solimania District

RIYADH - K.S.A

Name: Abrar Mansour Almunaysir.

Title: Deputy Qualified Person for Pharmacovigilance

Mobile:+966552567663

Telephone:+966114631299

Fax: N/A

Email ID:abrar.almunaysir@julphar.net

Address: SALAH ADEEN ST. AL BAIT BLDG, NO.1 First Floor: OFFICE NO.-1

Solimania District

RIYADH - K.S.A

OMAN

Name: Intisar Nasser Al-Rahbi

Title: Qualified person for pharmacovigilance

Mobile: +96892817165

Telephone: +96824605060

Fax: +96824603096

Email ID: Intisar.nasser@julphar.net

Address: Muscat - Oman , Madinate al sultan Qaboos - Way NO.2114 vila NO.764 - scientific pharmacy.

Name: Ashraf Aboushousha

Title: Deputy Local safety responsible

Mobile: 0096895962401

Telephone: 0096824605060

Fax: 0096824603101

EmailID: ashrafaboushousha@planetme.ae

Address: Muscat –Oman

UAE

Name: Syed Zaferuddin

Title: Qualified person for pharmacovigilance

Mobile : +971527125708

Telephone: +97172045493

Fax:

Email ID: syed.zaferuddin@julphar.net

Address: Administration Building, 3rd Floor, Airport Road, Digdaga, Ras al Khaimah,

Name: Dr. Rawya Al Kredly

Title: Deputy Qualified person for pharmacovigilance

Mobile : +971555905997

Telephone: +97172045439

Fax:

Email ID: rawya.kredly@julphar.net

Address: Administration Building, 3rd Floor, Airport Road, Digdaga, Ras al Khaimah,