Vigilance scope

انتظروا محاضرة مجانية تعريفية بعلم اليقظة ودورها ف عالم تصنيع الأدوية في الشركات الدوائية ودورها وماهو تعريف ال icsr
للتفاصيل علق ب follow وتابع البوست
This is a good opportunity to improve your skills and enhance your knowledge about the science of pharmacovigilance and the implementation of all aspects included in pharmaceutical companies and hospitals

انتظروا محاضرة تعريفية بعلم اليقظة ودورها ف عالم تصنيع الأدوية في الشركات الدوائية ودورها أيضا في سلامة المرضى ف المستشفيات
للتفاصيل علق ب follow وتابع البوست
This is a good opportunity to improve your skills and enhance your knowledge about the science of pharmacovigilance and the implementation of all aspects included in pharmaceutical companies and hospitals

Could you define the linkage between pharmacovigilance and drug safety
Follow these slides and for more information follow vigilance scope


safety

لو انت لسه خريج جديد أو حتي قديم وعاوز تعمل shift
في مجال جديد
لو حابب تشتغل في patient safety
لو عاوز تتعرف علي احد مجالات اليقظة ودورها في ICSR
اتعرف من خلال البوست علي patient safety program 👇👇

Patient support programs
Patient support programs (PSPs) are an ideal way for you to directly support patients, improve adherence and achieve better outcomes
Providing personalized interactions for better disease outcomes
At Ashfield we have a proven approach to creating successful patient support programs:

Design creative, tailored solutions to address specific therapy failure points
Use health psychology to understand the true drivers of non-adherence and develop care plans and materials that are personalized to patients’ needs
Deliver an exceptional experience to patients, carer partners and healthcare professionals
Establish an effective multichannel connection between stakeholders
At the core of our programs are our highly–skilled and trained Clinical Educator teams. They build strong, trusted relationships with patients using the channels and settings that work for those individuals, whether home visits, phone calls or video conferencing.

Our Clinical Educators help patients to understand their conditions, recognize the importance of adherence, from initial diagnosis and beyond. They’re also trained in health psychology techniques, which are shown to help patients cope and reduce anxiety, fatigue and depression.

Multichannel Patient Support Programs allow patients to quickly and conveniently access the information and support they need, when they need it through services such as helplines, apps, emails and educational websites.

To offer truly personalized care we use a patient-relationship platform, Health Cloud from Salesforce. This provides a single, detailed view of each patient and helps us provide the best patient experience. It also supports operational efficiency, particularly for integrated field and contact center based support programs.

Labeling
what does it mean?
Do you think that the label of a medicine is important in pharmacovigilance ?
How does labeling can work?
How does pv specialists can use the label to minimize the risk of a medicine 💊?

scope

يعد علم متابعة ورصد الآثار الجانبية للأدوية pharmacovigilance من أهم العلوم في مجال الصيدلة
ومن أفضل الطرق في الاستبيان عن الأثر النافع للدواء والآثار الضار.. كما أنه من أهم العلوم التي تستخدم في التجارب السريرية clinical trials بجانب أهميته في تتبع الدواء ومأمونية بقاءه أو سحبه إذا لزم الأمر..


scope

Follow vigilance scope to know all Pharmacovigilance updates, how does this science can limit the adverse events or detect the signals



Scope

The most important scope in PV

program
ICSR module
scope
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Individual case safety reports (ICSR) processing steps in pharmacovigilance (PV) This video contains information on ICSR (individual case safety reports) processing steps in pharmacovigilance. This video is particularly important for medi...

How does Pharmacovigilance work? Bayer is a Life Science company. One of our core competencies is improving people’s quality of life by preventing, alleviating, and treating diseases. The Ba...

يعتبر علم اليقظة من العلوم المهمة لرصد الآثار الجانبيةADR لأي مستحضر في أي مرحلة من مراحله قبل أو بعد التسويق أو حتي في فترة التجارب السريريةclinical trials وعمل خطة لإدارة المخاطرRMP ورفع safety
تعرف علي علم اليقظة ومجال تطبيقه
تابع البوستات القادمة للشرح بالتفصيل

Simple video about Epidemiology and its' role in pharmacovigilance


studies

Epidemiological Studies - made easy! This video gives a simple overview of the most common types of epidemiological studies, their advantages and disadvantages. These include ecological, case-se...

من أهم ملفات اليقظة
ملف خطة إدارة المخاطر ...
تعرف علي تعريف مصطلح RMP وايه أهم Content
وايه هي objectives لهذا الملف
تابع 👇
Risk Management Plan: GVP Module V
European Medicines Agency published Module V of Good Vigilance Practices in 2012 and it was later revised in April 2014. The main objective of this module is to harmonize the development of the Risk Management Plan and its use in the European framework.
A Risk Management Plan is a mandatory report, required by the EMA for all Marketing Authorization Applications and it may be required in any moment during product life-cycle. It is a very complex report that characterizes the safety profile of any medicine, it is an accurate planification of all pharmacovigilance activities, it collects all implemented and planned measures to minimize and mitigate risks and eventually, it evaluates the efectiveness of all these measures.
The proposal of the development of a RMP includes:
• To early identify any risk from all existing information
• To identify areas where there is a lack of information
• To determine future research procedures to identify or characterize risks in a scientific-based approach
• To assure that pharmacovigilance activities start before Marketing Authorization Application and continue during the life-cycle

GVP Module

EMA established a fixed structure that must be followed to develop RMPs that contains defined parts:
I. General Overview of the medicine
II. Safety Specification: It covers all important identified risks, important potential risks, missing information and gaps that must be taken into account for further information
III. Pharmacovigilance plan: to early identify and/or characterize any potential risk
IV. Plan for post-authorisation efficacy studies: Summary figure of planned studies with the agenda and protocols of all drafts should be submitted with the RMP
V. Risk Minimization Measures (Including all activities to assess effectiveness of these measures)
VI. Summary of RMP
VII. Annex


concern
_minimization_ measures
minimization_activities