Pre-conference programme (Tuesday - October 27, 2015)

 

  Tycho Kepler Stella
8:30 - 9:00 Registration
9:00 - 18:00 Pre-conference course 1
Risk management and risk minimization
Pre-conference course 2
Methodologies in Pharmacovigilance
Pre-conference course 3
Pharmacovigilance in MENA (Middle East and North Africa) region
       
19:00 - 21:30 Welcome reception

 



ISoP 2015 Pre-conference course 1 1

Risk management and risk minimization

ISoP experts offer an intensive one-day tutorial on essential concepts of risk management and risk minimisation in pharmacovigilance and drug safety to interested health professionals and participants with basic to intermediate background in the field.

8:30 - 9:00 Registration

Chair
Jan Petráček (Czech Republic)
9:00 - 9:10
Introduction to the Tutorial


Jan Petráček (Czech Republic)
9:10 - 9:30
Essential Knowhow for Risk Management of Pharmaceuticals
  Speaker Jan Petráček (Czech Republic)
9:30 - 10:05
Worldwide regulatory frameworks for Risk Management

Speaker Deirdre McCarthy (USA)
10:05 - 10:50
Medical Evaluation in Pharmacovigilance and Risk Management
  Speaker Gaby Danan (France)
10:50 - 11:05 Coffee Break
11:05 - 11:35
Documenting the Potential for Medication Errors – Good Practice Guidance 
  Speaker Thomas Goedecke (UK)
11:35 - 12:05
Modification of Risk Benefit Balance by Risk Management  
  Speaker Saad Shakir (UK)
12:05 - 12:35
Risk Minimisation via Safety Communication
  Speaker Priya Bahri (UK)
12:35 - 13:05   Individual Patients Risk Management
  Speaker Jiří Vlček (Czech Republic)
13:05 - 13:50 Lunch
13:50 - 15:30 Workshop in Design of Risk Management System
  Tutor Jan Petráček (Czech Republic)
15:30 - 15:45 Tea Break
15:45 - 16:40   Worldwide Differences in Approaches to Risk Management
  Speaker Yola Moride (Canada)
16:40 - 18:00   Pharmacovigilance Planning – Post-Authorisation Studies of Safety and Efficacy
  Speaker                 
Yola Moride (Canada)
18:00   Concluding remarks


ISoP 2015 Pre-conference course 21

Methodologies in Pharmacovigilance

This one-day course will be dedicated to Methodologies in Pharmacovigilance covering the entire processof signal identification, ranging from the evolution of adverse drug reactions reporting via the social networks and mobile applications, to the strategies of data-mining aimed at improving the early detection of potential signal of drug-related risk and their evaluation. The course will provide a general overview of the assessment of the benefit risk profile of drugs with practical examples provided by expert speakers which may be of interest for all Pharmacovigilance stockholders (industry, regulatory and academia).

8:30 - 9:00 Registration
  Chair
Radek Běla (Czech Republic)
9:00 - 10:00
Adverse events reporting: impact of clinical considerations

Speaker Marco Tuccori (Italy)
10:00 - 11:00   Advanced data collection methods (social media, active
surveillance, mobile technologies)
  Speaker Magnus Wallberg (Sweden)
11:00 - 11:15        
Coffee Break
11:15 - 12:15   Medical evaluation of ICSR (causality
assessment, seriousness expectedness)
  Speaker Ian Boyd (Australia)
12:15 - 13:15   Signal detection methodologies (clinical and statistical methods)
  Speaker Manfred Hauben (USA)
13:15 - 14:30 Lunch
14:30 - 15:30   Masking effect in signal detection
  Speaker Manfred Hauben (USA)
15:30 - 16:30   Signal verification methods (clinical and
pharmacoepidemiological approach)
  Speaker Marco Tuccori (Italy)
16:30 - 17:00 Tea Break
17:00 - 18:00   How Risk and Benefit relates..
  Speaker Eugene van Puijenbroek (The Netherlands)
18:00
Concluding remarks

ISoP 2015 Pre-conference course 31

Pharmacovigilance in MENA (Middle East and North Africa) region

This training course will provide you with an overview of the current pharmacovigilance situation and activities in the Middle East and North Africa (MENA) region. Participants will gain an insight on how Pharmacovigilance is developing, and local implementations of several pharmacovigilance activities will be discussed by key pharmacovigilance experts in the MENA region.

8:30 - 9:00 Registration
  Chairs
Adel A. Alharf (Saudi Arabia); Ghita Benabdallah (Morocco)
9:00 - 10:00   Guidelines for pharmacovigilance in Arab countries

Speaker Suzan Adel (Egypt)
10:00 - 11:00   New dynamics of pharmacovigilance in MENA region countries
  Speaker Houda Sefiani (Morocco)
11:00 - 11:15        
Coffee Break
11:15 - 12:15   Pharmacovigilance activities in GCC countries
  Speaker Adel A. Alharf (Saudi Arabia)
12:15 - 13:15   Risk Management Plans: from theory to practice
  Speaker Mohammed Alsbou (Jordan)
13:15 - 14:30 Lunch
14:30 - 15:30   Status of Pharmacovigilance in Arab and Eastern Mediterranean region member countries: Questionnaire study
  Speaker Souad Skalli (Morocco)
15:30 - 16:00 Tea Break
16:00 - 17:00
Pharmacovigilance terminology for Arab countries
  Speaker Nabiha Smiress (Morocco)
17:00
Concluding remarks

 

   
 
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