20th ACCSQ PPWG Delegate Handbook

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					                                                       DELEGATE HANDBOOK



                                                                nadfc




                                        the
                                        ACCSQ
                                             20    PPWG
                                                              th

                                        ASEAN CONSULTATIVE COMMITTEE
                                        FOR STANDARDS AND QUALITY-
                                        PHARMACEUTICAL PRODUCT
                                        WORKING GROUP
                                                           NUSA DUA
                                                           BALI
                                                           13-17 MAY
                                                           2013




SECRETARIAT 20THACCSQ-PPWG
Gabungan Perusahaan Farmasi Indonesia
Jl. Angkasa No. 20-A Kemayoran
Jakarta 10620, Indonesia
Phone : +62 21 420 3040,
Fax : +62 21 420 3047, 420 3048
E-mail : sekretariatgpfi@yahoo.com
                                                                               Welcome




                                               nadfc
                                                              the
                                                              ACCSQ
                                                                   20    PPWG
                                                                                    th

                                                              ASEAN CONSULTATIVE COMMITTEE
                                                              FOR STANDARDS AND QUALITY-
                                                              PHARMACEUTICAL PRODUCT
                                                              WORKING GROUP

                                                                                 NUSA DUA
                                                                                 BALI
                                                                                 13-17 MAY
                                                                                 2013

     All 20th ACCSQ PPWG Meeting activity will published at

       www.20thaccsq-ppwg.com
                              or

     accsq-ppwg20th.blogspot.com

50                                                                                           51
                                    Contents

            1. Meeting Venue and Dates       (5)
            2. Welcome Remarks               (6)
            3. Program Schedule              (10)
            4. Access to Procedures
               & Security                    (12)
    nadfc
            5. Accomodations                 (13)
            6. Transportation                (14)
            7. Meeting Facilities & Services (16)
            8. Venue Plan                    (19)
            9. Indonesia Overview            (20)
            10. A Glimpse of Bali            (23)
            11. Bali Nusa Dua
               Convention Center             (26)
            12. Map on Nusa Dua Area         (28)
            13. Bali Trip (optional)         (32)
            14. Acknowledgement              (40)
            15. Exhibitor List               (42)
            16. Bali Map                     (46)
            17. Contact Detail               (48)




2                                                   3
    Contact Details                                                                         Meeting Venue
                                                                                                and Dates
    ACCSQ-PPWG Meeting Information Desk:                                        The 20th ACCSQ-PPWG Meeting and
    - NADFC : 0813 8560 3005 (Mrs Anna)                                         related meetings take place in Bali,
    - Secretariat : 0812 2420423 (Mr Abdul Muid)
                                                                                Indonesia, 13-17 May 2013, at:
    Registration inquires, please visit
    www.20thaccsq-ppwg.com
                                                                                Bali Nusa Dua
    or                                                                          Convention Center
    accsq-ppwg20th.blogspot.com                                                 Kawasan Pariwisata
                                                                                Nusa Dua Lot NW/1,
    Registration Desk is located at South Lobby
    Bali Nusa Dua Convention Center                                             Nusa Dua, Bali 80363
                                                                                Indonesia
    Hotel Reservation Contact:
    PT MELALI BALI
    Jl. Dewi Sri, Complex The Lotus No.10
    Kuta 80361 – Bali, Indonesia
    Ph. +62 (361) 766156
    Fax. +62 (361) 763435
    info@melali-bali.com
    www.melali-bali.com
                                                                                                   Bali
    Mrs. Maria Yovieta, Reservation Coordinator
    M : +62852 3421 8484                                                                      Denpasar
    E : maria.yovieta@melali-bali.com


                                                                                                           Nusa Dua




         Designed by Mindmore Communication, Email : mindmoredesign@gmail.com
4                                                                                                                      5
    Welcome Remarks

    Dear Colleagues,

    It is my great pleasure to extend a very         With the tremendous
    warm welcome to all delegates and par-           milestones achieved so
    ticipants to the 20th ACCSQ PPWG Meeting.        far, it is reassuring to
    Indonesia is honored to host the fourth times    note that ASEAN’s drug
    of ACCSQ PPWG meeting. As ever, we are           regulatory authorities
    delighted to welcome you here at the island      continue to work in very
    of Gods to continue our important meeting.       close partnership with
    I am pleased to be able to see many friends      one another and with the
    from around the region in our midst today        pharmaceutical industry
    and I would like to express my personal          to ensure the smooth
    appreciation for your being here, and for the    functioning of implemented initiatives. I am
    collegiality that we have shared in ASEAN        also glad to note that the PPWG is exploring
    harmonization efforts over the years.            new areas for collaboration and harmoniza-
                                                     tion.
    As we all know, the Pharmaceutical Product
    Working Group or PPWG was established in         As the host, we are very glad to assist all of
    1998 by the ASEAN Consultative Commit-           you. So please do not hesitate to contact the
    tee on Standards and Quality. We have been       organizing committee members should you
    working under the principle of PPWG to pro-      need any assistance. Again, let me express
    mote drug registration, trade, and coopera-      my sincere welcome to all of you and wish
    tion as well as to eliminate technical barrier   you a fruitful and successful meeting and a
    to trade. The PPWG aims to harmonize “ASE-       most pleasant stay in Indonesia.
    AN Technical Requirement on Pharmaceuti-
    cal. To date, several significant achievements
    of the PPWG have been made, notably the          Dra. Lucky S. Slamet, M.Sc
    ASEAN Common Technical Dossier (ACTD),
    ASEAN Common Technical Requirement
    (ACTR), and other relevant technical guide-
    lines.




6                                                                                                     7
    Program
    Schedule




8              9
     Program Schedule
                     Day 1               Day 2                    Day 3                 Day 4                Day 5
      Time       May 13, Monday      May 14, Tuesday         May 15, Wednesday     May 16, Thursday       May 17, Friday

 MORNING       Registrastion       Technical                 Ballroom :           Continuation of the   09:00-12:00
 09:00-12:30   at BNDCC            Working Group
                                   (for All)
                                                             IWG Meeting
                                                             (for All)
                                                                                  20th ACCSQ-PPWG
                                                                                  Meeting
                                                                                                        Sight seeing

               Seminar (for all)   Room 1:                   Room 4:
               Ballroom            Q&A on Quality:           The GMP-MRA/JSC
                                   ACTR/ACTD & Guide-        Meeting
                                   lines                     (only for DRA)
                                   • ACTR & ACTD quality
                                   • Analytical Validation
                                      guideline
                                   • Process Validation
                                      guideline
                                   • Stability guideline
                                   • Variation guideline

                                   Room 2:
                                   • Q&A on Safety/
                                     Efficacy: ACTR/ACTD
                                   • TWG on Biologicals

                                   Room 3:
                                   BA/BE TWG & TF

                                   Room 4:
                                   The GMP-MRA/JSC
                                   Meeting
                                   (only for DRA)


 LUNCH BREAK                                                 LUNCH BREAK
 12:30-14:00                                                 12:30-14:00
 AfTERNOON     Continuation        Continuation              Opening Ceremony     Continuation          Adoption of the
 14:00-17:00   of Seminar          of Technical
                                   Working Group
                                                             of the 20th ACCSQ-
                                                             PPWG Meeting
                                                                                  of the 20th ACCSQ-
                                                                                  PPWG Meeting
                                                                                                        20th ACCSQ-PPWG
                                                                                                        Meeting
                                   (Room 1-3)
                                                             14:00-16:00                                (Ballroom)

                                   The GMP-MRA/JSC
                                   Meeting                   The 20th ACCSQ-
                                   (only for DRA)            PPWG Meeting
                                   (Room 4)                  16:00-17:30

 EVENING                           HOD Meeting &                                  Gala Dinner to All
 17:00-21:00                       Working Dinner                                 (BNDCC)

                                                                                  18:00-22:00




10                                                                                                                         11
     Access Procedures                                           Accomodations
     and Security                                   Hotels located nearby are as follows:
                                                    Novotel Nusa Dua Hotel
                                                    Jl. Pantai Mengiat BTDC Complex
     ID Badges                                      P.O BOX 116, Nusa Dua 80363 Bali
     It is mandatory that all guests have their     Ph. +62 361 8480 555, Fax. +62 361 8480 556
                                                    Distance from the venue: 1.7 km
     ID badge to pass the ID visual verification    ****(4 stars)
     and security check points in order to be       Price :
                                                    - Deluxe room          : Rp 1,200,000(US$ 123)
     able to access the Bali Nusa Dua Conven-       - One bedroom Suite : Rp 1,750,000 (US$ 184)
     tion Center.                                   - Two bedroom Suite : Rp 2,500,000 (US$ 258)

                                                    Melia Bali Nusa Dua Hotel
     All participant are requested to visibly       Kawasan Wisata BTDC Lot 1, Nusa Dua 80363 Bali
     display their ID badge at all times. ID        Ph. +62 361 771510, Fax. +62 361 771362
                                                    Distance from the venue: 1.1 km
     badge are required for entry into the meet-    ***** (5 stars)
     ing venue and to board shuttle busses.         Price :
                                                    - Deluxe room         : Rp 1,450,000 (US$ 148)
                                                    - Duplex Suite        : Rp 1,800,000 (US$ 188)
     ID Badges are available for pick-up at         - Lagoon Access Suite : Rp 3,200,000 (US$ 288)
     the ACCSQ-PPWG Meeting Registration            Nusa Dua Beach Hotel & Spa
     Desk at South Lobby of Bali Nusa Dua           Kawasan Pariwisata Lot North 4, Nusa Dua 80363 Bali
                                                    Ph. +62 361 77 12 10, Fax. +62 361 77 12 29
     Convention Center, during the following        Distance from the venue: 450 m
     time:                                          ***** (5 stars)
                                                    Price :
          Dates             Time                    - Deluxe room          : Rp 1,650,000 (US$ 168)
                                                    - Premier room         : Rp 1,850,000 (US$ 188)
       13 - 15 MAy 2013   08:00 - 16:00             - Palace Club room     : Rp 2,600,000 (US$ 268)
                                                    - Palace Club suite    : Rp 3,750,000 (US$ 388)

     Meeting Overpass                               Courtyard Marriot Hotel
                                                    Kawasan Pariwisata Lot SW1,Nusa Dua 80363 Bali
     ID badge and meeting overpass are required     Ph. +62 361 3003 888, Fax. +62 361 3003 888
     to enter main ACCSQ-PPWG session.              Distance from the venue: 1.8 km
                                                    ****(4 stars)
                                                    Price :
     Lost Badges                                    - Deluxe Garden room : Rp 1,400,000(US$ 143)
     Lost or missing badges should be immedi-       - Deluxe Pool view room Rp. 1,600,000(US$ 164)
                                                    - Premium Deluxe room Rp. 1,700,000(US$ 175)
     ately reported to the ACCSQ-PPWG Meeting       - Deluxe Pool Terrace : Rp. 2,050,000(US$ 210)
     Registration Desk located at South Lobby of
                                                   Hotel Reservation Contact:
     Bali Nusa Dua Convention Center.              Pt Melali Bali
                                                   Ph. +62 (361) 766156, Fax. +62 (361) 763435
                                                   info@melali-bali.com, www.melali-bali.com
                                                   Mrs. Maria Yovieta, Reservation Coordinator
12                                                 M : +62852 3421 8484, E : maria.yovieta@melali-bali.com   13
     Transportation

     For pick-up and delivery of participants         Shuttle Schedule
     from the airport to the hotel (or hotel to       Time tables for shuttle bus service are
     the airport), dealing directly with the hotel    available at ACCSQ-PPWG Information
     or come to taxi counter at the airport.          Desks at the meeting venue.

     Participants in need of taxi service may         Taxi
     also call a taxi service to request a pick-up.   It is highly recommended to use taxi cabs
     Information regarding transportation and         with special taxi service insignia.
     taxi services are available at ACCSQ-PPWG        Taxi stands are available at most major
     hospitality Desks at the designated hotels.      shopping centers or contact hotel for taxi
                                                      services.



                                                      ACCSQ-PPWG Meeting Information
                                                      Desk:
                                                      - NADFC : 0813 8560 3005 (Mrs Anna)
                                                      - Secretariat : 0812 2420423 (Mr Muid)

                                                      Registration inquires, please visit

     Travel time between the designated
                                                      www.20thaccsq-ppwg.com
                                                      or
     hotels from/to Airport is estimated at
     around one hour.
                                                      accsq-ppwg20th.blogspot.com
                                                      Hotel Reservation Contact:
     International Flight passengers are ex-
                                                      Mrs. Maria Yovieta, Reservation Coordinator
     pected to arrive two hours before depar-
                                                      M : +62852 3421 8484
     ture time. Participant are advised to make       E : maria.yovieta@melali-bali.com
     appropriate time arrangement.




14                                                                                                  15
     Meeting Venue
     Facilities & Services
     ACCSQ-PPWG Information Desk                   Secretariat Room
     and ACCSQ-PPWG Hospitality                    Secretariat rooms are available for use
     Desk                                          by government delegate and organizing
     The ACCSQ-PPWG Information Desk is lo-        committee and open from 08:00 to 20:00.
     cated at the South Lobby BNDCC and open
     from 08:00 to 17:00.
     ACCSQ-PPWG Hospitality Desks is available     Emergency Service
     only for Government Delegate at BNDCC         In case of an emergency (ambulance, fire
     and open from 08:00 to 17:00.                 or police, etc) please refer to the useful
                                                   telephone numbers on the inside back
     ACCSQ-PPWG Information Desk personnel         cover.
     are available to provide general meeting
     information, assist with shuttle informa-     Health facility located near the designated
     tion, distribute meeting support materials    hotel and meeting venue:
     and provide general assistance.
                                                   BIMC Hospital Nusa Dua Kawasan
     General inquiries regarding Bali can be       BTDC Blok D Nusa Dua 80363, Bali
     addressed to personel at the ACCSQ-PPWG       Phone : +62 361 3000 911
     Hospitality Desks. Visitors information and   Fax. : +62 361 3001 150
     guidebooks are requested to Hotel.
                                                   Fire                                 113
     Head Official Delegate (HOD)                  Police                               110
     meeting room                                  Ambulance                            118
     HOD meeting room is at Bali Nusa Dua          Ngurah Rai Taxi                   724724
     Convention Center.                            Bali Taxi                         701111
                                                   Public Hospital                   227911
     Prayer room
     Prayer room are located at Mezzanine floor
     at Bali Nusa Dua Convention Center.




16                                                                                               17
     Venue plan




18                19
                                                             Borobudur Temple             Jaran Kepang


     Indonesia overview

     Consisting of more than 17,000 islands, the
     vast Indonesian archipelago spans 5,120 km              Rinjani Mountain             Hombo Batu Nias

     across the equator, positioned between the Asia
     and Australia continents. Four-fifths of the area
     is sea with the major islands of Sumatera, Java,
     Kalimantan, Sulawesi and Papua.



              Prambanan Temple               Reog Ponorogo

                                                                   Geographically, Indonesia’s landscape is greatly
                                                                   varied. Java and Bali have the most fertile
                                                                   islands and rice fields are concentrated in these
                                                                   two regions, whereas Sumatra, Kalimantan,
                                                                   Sulawesi, Maluku and Papua are still largely
                                                                   covered with tropical rainforest.
                  Legong Dancer              Komodo Island
                                                                   Open savannah and grassland characterize
                                                                   Nusa Tenggara.

                                                                   The lowland that comprise most of Indonesia
                                                                   has a characteristically tropical climate with
                                                                   abundant rainfall, high-temperatures and hu-
                                                                   midity. Rainy Indonesia’s tropical climate and
                                                                   unique geographical character provide shelter
                                                                   for flora and fauna that are as diversely rich as
     The 300 ethnic groups that exist
                                                                   its land and people.
     harmoniously give birth to a potpourri
     of cultures and fascinating people.                           The plant and animals in Indonesia’s western
                                                                   region represent that of mainland Asia while
     The major ethnic groups are: Minangkabaunese,                 those in the eastern region are typical of Aus-
     Malay, Javanese, Sundanese, Maduranese and                    tralia. Endemic species, which are the pride of
     Ambonnese. Arab, Chinese and Indian immi-                     Indonesia exist in the central region, such as
     grants have also settled in regions throughout                orangutans, tigers, one-horned rhinos, el-
     the country, particularly in the coastal cities.              ephants, dugongs, anoas and komodo dragons.

20                                                                                                                     21
Wayang Kulit                                     Ukiran Jepara


                                                                          A Glimpse of Bali

                                                                 Bali is the famous island of the Indonesian
                                                                 archipelago.
Batik                                            Wayang Golek

                                                                 As the ‘Island of the Gods’ there are the
                                                                 combination of the friendly people, the natural
                                                                 attractions, the great variety of things to see
                                                                 and do, the year-around pleasant climate, and
                                                                 the absence of security problems.




        The warm tropical waters of the archipelago
        nurture a rich marine environment that holds
        a myriad of fish, coral species and marine
        mammals.

        A cultural heritage passed on through genera-
        tions offers a wealth of traditional arts and
        crafts. Batik, wooden carvings, weavings,
        silverworks and many other traditional skills
        produce exquisitely beautiful items.


        Indonesia’s multi-racial and multi-re-
        ligious culture mean festivals steeped
        in traditions are celebrated through-
        out the year.                                            And there is Bali’s special ‘magic’,
                                                                 which is difficult to explain. The mo-
        Frequently featured in these events are dances,          ment you feel the magic of this island,
        wayang theaters and other performing arts.               you are addicted for the rest of your
                                                                 life.




22                                                                                                                 23
     Geographically, Bali lies between the            The wide and gently sloping southern regions
                                                      play host to Bali’s famed rice terrace among
     islands of Java and Lombok. Bali is
                                                      some of the most spectacular in the world.
     small, stretching approximately 140
     km from east to west 80 km from                  In the hilly, northern coastal regions, the
     north to south.                                  main produce is coffee, copra, spices,
                                                      vegetables, cattle and rice.
     The tallest of a string of volcanic mountains
     that run from the east to the west, is Gunung
     Agung, which last erupted in 1963.

     Lying just 8 south of the equator, Bali boasts
     a tropical climate with just two seasons (wet
     and dry) a year and an average annual tem-
     perature of around 28oC.




24                                                                                                   25
     Bali Nusa Dua
     Convention Center




     Nusa Dua is the premier resort area in Bali.   The whole concept consists of a high
     The vicinity has an excellent tourism infra-
                                                    profile characteristic, an impressive
     structure with more than 4000 available
     rooms of international 4 and 5-stars chain
                                                    70,000 sq.m garden landscape and a
     hotels, a close by 18-holes Golf & Country     breathtaking Balinese architecture of a
     Club, Amphitheatre, alongside luxurious        total 25,000 sq.m building area which
     shops, Cafe and Restaurants with a seamless    all integrated to create a complete infra-
     white sandy beach within a walking distance.
                                                    structure for any kind of events.
     Within this alluring atmosphere, Bali Nusa
                                                    Each detail is developed with our commitment to
     Dua Convention Center (BNDCC) offers a
                                                    wholeheartedly demonstrate our work in the most
     promising eminence with its desirable loca-
                                                    professional way.
     tion and compelling excesses.




26                                                                                                    27
     Bali Sightseeing Tours                                Tour MB 2
                                                           Mystical Uluwatu & Jimbaran
     While visiting Bali we invite you                     Bay Seafood Dinner
                                                           Pick up from your hotel
     to enjoy a few of the most spec-                      in the late afternoon.
     tacular sights and performances                       Along a winding road
     the island of gods has to offer.                      you will drive to one of
     We will build memories you will                       the most holy temples
     never forget. To reserve one or                       of Bali. “ULUWATU-
                                                           Temple” located on the
     more of these selected tours fill                     most southern tip of the peninsula, on a cliff
     out the reservation form, have it                     100 m above the ocean. During sunset, at-
     faxed/emailed to us.                                  tend the mystic and well-known “Kecak dance”
                                                           (subject to performance schedule and weather)
     Tour MB 1                                             after this beautiful but mysterious spectacle,
     The Barong Dance To Tanah Lot                         drive to the romantic “Jimbaran Bay” to enjoy
     Depart early in the morning to watch the              a delicious seafood-dinner in a romantic atmos-
     Barong and Keris Dance                                phere right on the beach.
     performance in Kesiman,                               After dinner, transfer back to your hotel.
     after this beautiful spec-                            Time : 16.30 – 21.30 | USD 65
     tacle drive up to Sangeh                              (Includes dinner)
     - the sacred monkey for-
     est, where hundreds of                                Tour MB 3
     them would comfortably                                Kintamani Vulcano & Kehen
     encounter with people.                                Temple
     Driving northward on a
     back road that meanders
     through stunning rice
     terraces, to the village of
     JATILUWIH.

     This rustic and rural hilltop village is pleasantly
     cool and set amidst striking scenery. Next visit
     the charming TAMAN AYUN ROYAL TEMPLE of               We begin our tour with a visit to Pura Kehen,
     Mengwi. TANAH LOT will be thelast stop, popu-         a public temple located north of Bangli which
     lar and the most photographed temples on the          is often described as the miniature version of
     island for good reason.                               Pura Besakih. Drive up to Penglipuran Village to
     Time : 08.30 – 16.30 | USD 50                         enjoy a traditional countryside owning unique
                                                           characteristic life, socializing and culture.

28                                                                                                            29
     The natural nature and environments of coun-         Visit the Kertagosa or
     tryside is designating the pittance touch of         Royal Court of Justice,
     modernization influence. Proceed to Kintamani,       once the High Court
     the most favourite tourist destination, where        of the land. Next to
     you may enjoy a magnificent views of Mount           Kusamba, to Goa Lawah
     and Lake Batur. Next visit is Tegallalang, a well-   or Bat Cave Temple.
     known area to the north of Ubud and is the           Next visit Traditional
     major area for handicrafts production in Bali.       Village of Tenganan and
     This village offers beautiful panorama of rice       Tirta Gangga Water
     terraces in a river valley.                          Palace. This water com-
     Time : 08.30 – 16.30 | USD 50                        plex was built by the
                                                          old King for recreational
                                                          purposes and offers
     Tour MB 4                                            fantastic sceneries. Next
     Souvenir Hunting &Ubud Tour                          visit Sibetan Village, well known for its Salak
     Start your day with a                                (Snake Skin Fruits) plantations. Time: 08.30-
     morning walk around                                  16.30 | USD 50
     the artists’ village Ubud.
     Explore the different art                            Tour MB 6
     galleries, the traditional                           White Water
     market, the small temple                             Rafting
     and monkey sanctuary,                                Experience the spec-
     drive up to Tampaksir-                               tacular white water
     ing and stop at the holy                             adventure on Ayung
     spring temple of Tirta                               River. Experience the
     Empul situated next to                               beauty of Bali through
     the Presidential Palace.                             the pure nature, luscious jungle, and lovely
     Next stop will be at the                             terraced ricefield. Nothing breaks the silence
     elephant cave temple                                 except the sound of the jungle and the rush of
     -- Goa Gajah. Finally we visit the silver & Gold     the river. This tour is good for both rafter and
     galleries in Celuk before completing the tour.       people who have never done it before. Inclu-
     Time : 08.30 – 14.30 | USD 50                        sions: hotel transfers, lunch, river guides, all
                                                          necessary equipment, insurance.
     Tour MB 5                                            Time : 08.30 – 14.30 | USD 65 Includes lunch
     Ancient Karangasem
     Kingdom Tour                                         Tour MB 7
     Stop in KLUNGKUNG, well known as the old             Bali Bird Park & Bali Zoo Park
     cultural centre of Bali. The King of Klungkung is    Visit
     regarded as the most exalted Prince among the        With more than 1.000 birds of over 250 differ-
     Balinese aristocracy.                                ent species housed within lush tropical gardens,
                                                          the Park is renowned for its dedication to
30                                                                                                           31
     perfection and has                                     Enjoy a sumptuous BBQ and buffet lunch, with
     already become one of                                  a limitless array of delectable eatables, includ-
     Bali’s most visited des-                               ing many Balinese specialities for you to try.
     tinations. Devoted not                                 Back to Benoa before sunset. (Return hotel
     only to birds, the park                                transfers are included).
     is also a botanical oasis                              Time 08.30-17.30 | USD 95 includes lunch
     and gardeners’ paradise.
     More than 300 exotic trees and other plants are        Tour MB 9
     on display, some of them of great rarity and           Kuta Waterbom
     difficult to cultivate. The collection is constantly   Visit
     increasing as new species are added from               Exciting water slide
     around the world. Proceed to Bali Zoo Park,            slice through 3.8 hec-
     a tropical wildlife in Paradise. It is the perfect     tares of landscaped
     wildlife conservatory for 350 animals, mammals         tropical parks providing
     and reptiles.                                          hours of fun and enter-
     Time : 08.30 – 14 30 | USD 50                          tainment for the young and young at heart!.

     Tour MB 8                                              There are 101 ways to fill 24 hours each day
     Day Cruise To Nusa Lembongan                           with thrilling activities on land and in water. For
     Island                                                 relaxation, drift leisurely in a tube raft or go for
     Visit Lembongan island                                 a tranquil dip in inviting blue pools. A soothing
     by luxury catamaran                                    massage or spa treatment is the ultimate way
     which leaves daily from                                to unwind. Set your own pace for a day
     Benoa. Sail out into the                               of fun in the sun or relaxation in the shade.
     Badung Strait, relax and
     enjoy your refreshment                                 Perfect for the whole family or for that special
     including tea, coffee, and                             getaway. World-class slides and rides are built
     pastries on board. After                               and maintained to strict international safety
     arrival at Lembongan                                   standards. Advanced salt chlorination technique
     do as much activities as                               is soft on the earth and your skin. A roving
     you like. Visit a typical                              photographer will capture your fun on film so
     Balinese village with its                              you can cherish the wonderful memories.
     underground house or                                   Time: 08.30-14.30 | USD 50
     swim in the crystal clear lagoon or back on the
     golden sandy beach.                                    Tour MB 10
                                                            Treasure Island Cultural Park
     Water sports such as snorkeling, banana boat           The New Treasure Island Cultural Park in Toh-
     ride (unlimited), semi submarine, pearl farming        pati offers a hands-on, Cliff’s Notes version of
     tour are available for free. Diving, massage and       the Bali cultural experience.
     parasailing are available on optional.

32                                                                                                                 33
     The park is simply a se-                             Participants actually walk on the bottom, rather
     ries of open-air roofed                              than swim while numerous exotic fish and sea
     platforms constructed                                life surround them. Guest will have 20 minutes
     around a grassy plaza.                               of actual underwater time to a maximum depth
     The open area is shad-                               of 15 feet. Time : 08.30 – 14.30 | USD 65
     ed by numerous trees.
                                                          Tour Mb 12
     Several aspects of Ba-                               Jeep Safari
     linese culture are fea-                              Explore the wonders,
     tured in the park, which                             see the real and the
     you can participate in                               most exotic part of
     for yourself. The staff                              Bali, we offer you
     are all clad in tradition-                           Bali 4WD (4 wheel
     al Balinese outfits. Most                            drive) jungle jeep adventure tour. This tour
     are specialists in a certain category of Balinese    is designed for those people who love natural
     culture, and are stationed in one place where        beauty. The tour takes you through some of the
     visitors can come to them to observe and learn.      most beautiful countryside and tropical rain-
     Lessons and Activities include making Balinese       forest in Bali. Along the way you will receive a
     cake, making Balinese offering, gamelan music        complete commentry from the experience tour
     and dance, wearing Balinese Costume, batik           guides about balinese culture, flora& fauna, and
     lesson and handicraft painting. Visitors are         beautiful scenery with many opportunities to
     encouraged to walk from station to station.          stop for photographs.
     Time : 08.30 – 14.30 | USD 50                        Time : 08.30 – 17.30 | USD 85 Includes
                                                          lunch
     Tour MB 11
     Seawalker                                           Terms and Conditions :
     Located in the tourist                              • All prices include the services mentioned in the de-
     area of Sanur, Seawalk-                               scriptions, transportation, entrance fees, donations and
     er would be an unfor-                                 Enclish speaking guide (other languanges on request)
     gettable experience. You                            • Children under the age of 12 years will travel at 50%.
     can walk right on the
     bottom of the ocean and
     witness the sea life of all                         Reservation Contact :
     kind.                                               PT MELALI BALI
                                                         Jl. Dewi Sri, Complex The Lotus No.10
                                                         Kuta 80361 – Bali, Indonesia
     As a safe and exciting underwater adventure         Ph. +62 (361) 766156, Fax. +62 (361) 763435
     Sea Walker is a unique diving system providing      info@melali-bali.com, www.melali-bali.com
     an opportunity to observe the underwater world      Mrs. Maria Yovieta, Reservation Coordinator
     up to a depth of 15 feet without certification,     M : +62852 3421 8484
     and without getting your hair wet.                  E : maria.yovieta@melali-bali.com

34                                                                                                                  35
     Map on
     Nusa Dua Area




                                      Nusa Dua Beach Hotel & Spa
                   Bali Nusa Dua         H
               Convention Center




     Courtyard Marriot Hotel H
                         H Novotel Nusa Dua Hotel




36                                                                 37
     Map on
     Nusa Dua Area




38                   39
     Acknowledgement




      GP faRMaSI IndOnESIa




40                           41
     Exhibitor List
              Brunei Darussalam
                                                     Actavis
             (Bureau Food and Drug)               Combiphar
                    Cambodia                     Dexa Medica
     (Department of drugs and Food Ministry
              of Health of Cambodia)
                                                    Equilab
                    Indonesia                      Fahrenheit
      (The National Agency of Drug and Food     Ferron Pharma
                      Control)
                                                   Indofarma
                     Lao PDR
          (National Regulatory Authority)        Kalbe Farma
                     Malaysia                       Konimex
         (National Pharmaceutical Control
                                                    Landson
                      Bureau)
                    Myanmar                       Mersifarma
         (Myanmar Food and Drug Board           Novell Pharma
                   of Authority)              Otto Pharmaceutical
                   Philippines
          (Drug and Food Administration          Kimia Farma
                    Philippines)                  Pharmacore
                    Singapore                   Pharma Metric
            (Health Science Authority)
                     Thailand
                                               Pharos Indonesia
        (Thailand Food and Drug Agency)          Sanbe Farma
                     Vietnam                      Soho Group
        (Drug Administration of Vietnam)
                                               NN Pharmaplan
42                                                                  43
44
     Bali Map




45
     Note




46          47
     Contact Details

     ACCSQ-PPWG Meeting Information Desk:
     - NADFC : 0813 8560 3005 (Mrs Anna)
     - Secretariat : 0812 2420423 (Mr Abdul Muid)

     Registration inquires, please visit
     www.20thaccsq-ppwg.com
     or
     accsq-ppwg20th.blogspot.com

     Registration Desk is located at South Lobby
     Bali Nusa Dua Convention Center

                                                      All 20th ACCSQ PPWG Meeting activity will published at
     Hotel Reservation Contact:
     PT MELALI BALI
                                                          www.20thaccsq-ppwg.com
     Jl. Dewi Sri, Complex The Lotus No.10                                            or
     Kuta 80361 – Bali, Indonesia
     Ph. +62 (361) 766156
                                                      accsq-ppwg20th.blogspot.com
     Fax. +62 (361) 763435
     info@melali-bali.com
     www.melali-bali.com
     Mrs. Maria Yovieta, Reservation Coordinator
     M : +62852 3421 8484
     E : maria.yovieta@melali-bali.com


     BIMC Hospital Nusa Dua Kawasan
     BTDC Blok D Nusa Dua 80363, Bali
     Phone : +62 361 3000 911
     Fax.   : +62 361 3001 150
     fire                                113
     Police                              110
     Ambulance                           118
     Ngurah Rai Taxi                  724724
     Bali Taxi                        701111
     Public Hospital                  227911
                                                    Designed by Mindmore Communication, Email : mindmoredesign@gmail.com
48                                                                                                                         49

				
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