www.ispe-indonesia.

org

2015
ISPE Indonesia
Annual Conference

May 19th - 20th, 2015, Holiday Inn Hotel, Kemayoran, Jakarta

Managing Compliance Through

Effective and Efficient Operation

ACCREDITED BY IAI

Ikatan Apoteker Indonesia

Conference Highlight
The quality compliance is a challenge to pharmaceutical industry around
the world and need continuous review and improvement considering the intended
use of the medicinal product, which are life saving, restoring health and preserve
health as well as enhancing quality of life. Pharmaceutical industry should comply
with the regulation and haphazard operation cannot be tolerated so do not place
patients at risk and even fatal due to inadequate safety, quality or efficacy. This will
need full commitment of the top management regarding compliance to GMP and
regulation, review all systems and compliance measurements.
However the compliance and all the subsequence efforts to achieve, are always
perceived as high cost operation, especially in the era of tight competition in this
decade. Therefore management should also be able to review their cost structure
and implement effective and efficient operation without compromising quality, and
understand that actually compliance effort is a quality cost reduction. Several ways
to achieve this objective are among others, by applying LEAN concept with reliable
& robust process and improve productivity across company.
This 2-days conference will provide all participants with knowledge on compliance
measures , review and plan productivity improvement in operation as well as the
importance of Management Review.

2015 ISPE Indonesian Annual Conference

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Date and Venue

Date :
May 19th 20th, 2015
Congress Venue :
Holiday Inn Hotel, Kemayoran, Jakarta
Jl. Griya Utama Blok B No.1 Jakarta 14350

Important Program
Opening Ceremony & Keynote by Head of National Agency of Drug
and Food Control of Republic of Indonesia:
Tuesday, May 19th, 2015
Conference:
Tuesday & Wednesday, May 19th & 20th, 2015
Exhibition:
Tuesday & Wednesday, May 19th 20th, 2015
Election of ISPE Indonesia Affiliate President:
Tuesday, May 19th, 2015

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2015 ISPE Indonesian Annual Conference

Speakers
Linda Ambrose
Head of Ambrose Consulting Ltd., Developing Quality Mindset, Thailand
United Kingdom

Shigehiro Tahara
Director of CM Plus Corporation
Japan

Dra. Maura Linda Sitanggang, Ph.D

Director General of Pharmaceutical and
Medical Devices Ministry of Health
Indonesia

Sayekti Sulisdiarto
Corporate Technical Advisor Mensa Group
Indonesia

Wiwy Sasongko
IMS Health Indonesia

And more to come

2015 ISPE Indonesian Annual Conference

03

Tentative
Topics Agenda
The schedule can be changed without notice.

Day 1, May 19th, 2015

08.00 08.45

Registration

08.45 09.40

Opening

09.40 10.10

Keynote (KaBadan POM)

Dr. Roy A Sparringa M.App. Sc., Head of National
Agency of Drug and Food Control of Republic of Indonesia

10.10 10.45

Break

10.45 11.30

Improvement of Accessibility of Quality Medicine for

Universal Health Coverage
Dra. Linda Sitanggang, Ph.D., Director General of
Pharmaceutical and Medical Devices, MOH of Republic
of Indonesia

11.30 12.15

Current Indonesian Pharmaceutical Market Landscape

Wiwy Sasongko , IMS Health Indonesia

12.15 13.00

Regulatory Control Perspective on Pharmaceutical Industry

Compliance
Dra. Togi J. Hutadjulu MHA. Director Production Control of
Therapeutic Products and Household Products, NADFC

13.00 14.00

Lunch

BREAKOUT SESSION
Track 1
14.00 14.45

Cost of Quality

14.45 15.30

Break

15.30 16.15

Quality Metric

Track 2
14.00 15.00

Lean Manufacturing

15.00 15.45

Break

15.45 16.30

Lean Qualification
Shigehiro Tahara, Director of CM Plus Corporation, Japan

16.15 18.00
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Election of ISPE Indonesia Affiliate President

2015 ISPE Indonesian Annual Conference

Tentative
Topics Agenda
The schedule can be changed without notice.

Day 2, May 20th, 2015

BREAKOUT SESSION
Track 1
09.00 09.45

Data Integrity

09.45 10.15

eQMS

10.30 11.00

Break

11.00 11.45

GMDP (Good Manufacturing & Distribution Practice)

11.45 12.30

Quality System review

12.30 13.30

Lunch

Track 2
09.00 09.45

Value Stream

09.45 10.15

TBD

10.30 11.00

Break

11.00 11.45

Energy Saving

11.45 12.30

Productivity Improvement through Communication Skill

12.30 13.30

Lunch

PLENARY
13.30 14.30

Process Waste

14.30 15.30

Process and Product Performance Review and Continuous

Improvement

15.30 16.00

Break

16.00 17.00

Management Review

17.00

Closing

2015 ISPE Indonesian Annual Conference

05

Who Should Attend

Decision makers at top and middle management levels, the technical
leaders and professionals responsible for drugs development in
R&D, Regulatory Affairs, Process Development, Production, QA&QC,
Engineering and Human Resource Development from manufacturers
and distributors, consultants, Regulators and academia.

Sponsor / Exhibitors
Brand your company to industry decision makers through table-top
and booth exhibition
Share knowledge to participants from various industry decision makers,
regulators and academia through presentation opportunity
Business opportunity by direct interact with client.

06

2015 ISPE Indonesian Annual Conference

Registration Form
Seminar Fee
ISPE Indonesia Affiliate Member*

: IDR 2.500.000

*10% Discount for minimum 2 participant from same company

Non ISPE Indonesia Affiliate Member

: IDR 3.500.000
Lecturer
: IDR 1.250.000
Student
: IDR 450.000/Day
Cancelation before May 1st, 2015, 50% refundable
Seminar Track Choice*: Please choose Track 1 or Track 2
Track 1

Track 2

Please fill in with capital letters:

Complete Name:
ISPE member, No.
Non Member ISPE
Main Business*
Pharmaceutical Industry
Distributor
Consultant
Academia
Government Institution
Suppliers and other pharmaceutical industry service
Other (please specify)
Company*
Address
Department*
Job Position*
E-mail address*
Phone No.
Fax No.
*(Required to be filled)

2015 ISPE Indonesian Annual Conference

07

Registration Form
Please transfer registration fee to:

Please send registration form to:

ISPE Indonesia

PT Pharma Pro International

A/C No. 0713019060

PIC

Bank Central Asia (BCA)

Phone : (021) 6386.9502, ext.115

Fatmawati Branch

Fax

: (021) 6386.9503/05

Jl. Rs. Fatmawati No. 1CD

Email

: secretariat.ispeind@gmail.com

: Ms. Gita (+62812-9181-0522)

gita@pharma-pro.com
wendy@pharma-pro.com
Website : www.ispe-indonesia.org
Please specify participants name/ company on the bank transfer receipt.
Along with bank transfer receipt at the latest by April 25th, 2015
ISPE INDONESIA CONFERENCE SECRETARIAT:
PT. Pharma-Pro Int.
Phone
: +62-21-63869502 Ex. 115,
Fax
: +62-21-63869503/05
Mobile
: +62812 9181 0522 (Ms. Gita)
+62812 1880 2756 (Ms. Wendy)
Email
: secretariat.ispeind@gmail.com
wendy@pharma-pro.com or gita@pharma-pro.com

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2015 ISPE Indonesian Annual Conference

CONGRESS ORGANIZER/SECRETARIAT
Medical Conference Organizer (MCO) By
PT. Pharma-Pro International
Perkantoran Duta Merlin block C / 35 37
Jl. Gajah Mada no 3 5 Jakarta 10130, Indonesia
Phone: +6221-63869502, ext. 115
Fax: +6221-63869503/05
Mobile: +62812-91810522 (Gita)
Email: secretariat.ispeind@gmail.com/gita@pharma-pro.com/wendy@pharma-pro.com
MCO is certified by Indonesia Authority of MICE Industry and registered trademark of
PT. Pharma-Pro International. This name is protected by Indonesia copyright laws