Good Pharmacovigilance Course

Home Inauguration of

International Society of Pharmacovigilance – Indonesia Chapter

and

Good Pharmacovigilance Practice Course

Note :

1. This first course of Goof Pharmacovigilance Practice (Indonesia) is held in conjungtion with Home Inaguration of International Socienty of Pharmacovigilance – Indonesia Chapter

2. There are two types of certificates : Certificate of attendance and certificate of Good Pharmacovigilance Practice

3. All course attendants need to attend the whole event to gain certificate of attendance

4. All course attendants need to attend the whole course, do the pre-test and pass the post-test, in order to gain the certificate of Good Pharmacovigilance Practice

Itineraries

Thursday, 16th November 2017

08.30 – 09.00 Registration

Soft Lauch of ISOP Indonesia Chapter

09.00 – 09.10 Opening remarks (Head of Event Commitee)

09.10 – 09.30 Opening remarks (including short panel of current PV situation in Indonesia), President of ISOP Indonesian Chapter (dr. Jahrir Attorbahri, PhD)

09.30 – 09.45 Remarks from MOH

09.45 – 10.00 Remarks from BPOM RI (Indonesian regulatory agency)

10.00 – 10.15 Launching of ISOP Indonesia chapter

10.15 – 10.30 BREAK

Good Pharmacovigilance course (GPV) – Session I

10.30 – 11.00 Pre-test

11.00 – 12.00 What is and Why do we Need Pharmacovigilance (PV) ? (dr. Jahrir Attorbahri, PhD)

12.00 – 13.00 LUNCH BREAK

Good Pharmacovigilance course (GPV) – Session II

13.00 – 14.00 Fundamental Clinical Aspects of ADRs (Prof. dr. Rianto Setiabudi - TBC)

14.00 – 15.00 PV requirement and regulations in Indonesia (BPOM)

15.00 – 15.15 BREAK

Good Pharmacovigilance course (GPV) – Session III

15.15 – 16.15 Communication skill for PV (Widya Buenastuti, SH, MM)

16.15 – 17.00 Communication skills workshop (ISOP Indonesia Chapter – team)

Friday, 17 November 2017

08.30 – 09.00 Re-registration

Good Pharmacovigilance course (GPV) – Session IV

09.00 – 09.15 Wrap up first day (dr. Grace Wangge, PhD)

09.15 – 10.15 Important ADRs and ‘Risk Driving’ ADRs of Important Medicines (dr. Grace Wangge, PhD)

10.15 – 10.30 BREAK

Good Pharmacovigilance course (GPV) – Session V

10.30 – 11.30 ‘Individual Case Safety Reports’ (‘ICSRs’) (Dra.Sally Lelolita, Apt. Mkes.)

11.30 – 13.00 ISHOMA – Friday Prayer

Good Pharmacovigilance course (GPV) – Session VI

13.00 – 14.00 Spontaneous ICSR Reporting System (SRS) (Fachria Evi Yanthi, S.Farm, Apt)

14.00 – 15.00 Pharmacovigilance and Risk Management Systems and Risk Management Plans (RMPs) ( Evi Dwi Nofiarny, Ssi, Apt, MSc.)

15.00 – 15.30 Post test

15.30 – 15.45 BREAK

15.45 – 16.00 Certificate endorsement and Closing