we innovate. we collaborate. we lead. we are pappi. issue4_2018.pdfthe 25 th accsq-ppwg mee˝ng was...

R i g h t D o s e o f N e w s . F o r m u l a t e d b y and f o r P h a r m a c i s t s .

Year 2018. Issue 4 September 2018

We Innovate. We Collaborate. We Lead. We Are PAPPI.We Innovate. We Collaborate. We Lead. We Are PAPPI.We Innovate. We Collaborate. We Lead. We Are PAPPI.We Innovate. We Collaborate. We Lead. We Are PAPPI.

� Message from the

President

� Highlights from the

25th ACCSQ-PPWG

Mee�ng

� PAPPInspire: I am a

Survivor, A Cancer

Survivor

� Genera�on Bridge:

World Pharmacists

Day Edi�on

� WPD Photo Contest

� July to September

Birthday Celebrants

WHAT’SINSIDE:

Year 2018. Issue 4 page 2

GREETINGS to our fellow Pharmacists!

World Pharmacists Day is celebrated globally every 25th

of September. This event highlights the value of the

pharmacy profession in improving health in every corner

of the world.

“Pharmacists: Your Medicines Expert” is this year’s

theme for World Pharmacists Day. According to

Interna�onal Pharmaceu�cal Federa�on (FIP) President

Dr. Carmen Peña, “The theme of World Pharmacists Day

emphasizes that pharmacists are a trusted source of

knowledge and advice, not only for pa�ents but for

other healthcare professionals.” The theme also

provides an opportunity to showcase how pharmacy

works with other parts of the other healthcare system,

Dr. Peña added: “We work with other healthcare

professionals to ensure that every individual receives

op�mal treatment.”

In the Philippines, the theme was contextualized along

with the PPhA vision and will resonate as “The Filipino

Pharmacists: Your Caring Medica�on Experts.” PPhA had

adopted the Pharma Roadshow, a successful program of

the Davao City Chapter, whose objec�ve is to promote

awareness on the value of pharmacists and their

services to the community through health educa�on,

counselling and interac�ve ac�vi�es for the people in

chosen barangays. PPhA local chapters and affiliates are

encouraged to work with local communi�es to focus on

providing direct service to the community instead of the

usual celebra�on.

PAPPI will be collabora�ng with Metro Laylayan, one of

the Angat Buhay programs of the Office of the Vice-

President. Since 2017, PAPPI has been suppor�ng Metro

Laylayan in its effort to upliD the lives of the poor,

par�cularly children and senior ci�zens in various rural

areas in the Philippines. Details of the ac�vity will be

shared to PAPPI once Metro Laylayan has iden�fied the

community we will be working with.

This is the 2nd

year that we are holding our GMM as

PAPPI’s way of celebra�ng World Pharmacists Day. We

hope that the learnings

from today’s scien�fic

session will enhance our

competencies as

medica�on experts in

various seFngs from the

educa�onal system to

research and

development, to

regulatory compliance,

to ac�ve involvement in shaping policies and

regula�ons, to quality assurance, to access to medicines

and to transforming pa�ents’ needs into services like

pa�ent educa�on and counselling.

As medica�on experts, pharmacists play a vital role in

the pa�ent care con�nuum and can definitely do more

to improve the outcome of medica�on management in

the Philippine healthcare system.

Happy World Pharmacists Day!

Cheers to the Filipino Pharmacists!

Highlights from the 25th ACCSQ-PPWG Meeting By Armi Grace B. Gonzales, R.Ph.

The 25th

ACCSQ-PPWG Mee�ng was held on August 6-10 this year in the

beau�ful coastal city of Da Nang, Vietnam. The week-long mee�ng of the

Agency regulators as represented by each of the ASEAN member

countries plus representa�ves from ASEAN Pharmaceu�cal Club (APC)

and ASEAN Pharmaceu�cal Research Industry Associa�on (APRIA), proved

to have been produc�ve towards the aim of harmonizing the regula�ons

of registering pharmaceu�cal products within the region making both

innova�ve and established medicines accessible to target pa�ents.

Regulators from the Philippine Food and Drug Administra�on were

represented by AIy. Emilio L. Polig, Jr. (OIC for Field Regulatory

Opera�ons Office) as Head of Delega�on, Ms. Jesusa Joyce N. Cirunay

(Director II, Field Regulatory Opera�ons Office) and Mr. Wenzel C. Asprec

(OIC for Licensing and Registra�on Division, CDRR) .

As a regulatory professional and part of the industry observers, the

following relevant points were noted as discussed by the Technical

Working Group (TWG) and adopted by the Implemen�ng Working Group

(IWG):

Biologics and Vaccines TWG:

• Addi�on of the requirement to provide cold chain shipping

valida�on, as applicable for Biologics

• Revision of the defini�on of ‘excipient’ to align with the EMA

guideline on the excipients in the dossier for applica�on for

marke�ng authoriza�on of a medicinal product, which is now

defined as ‘cons�tuents of a pharmaceu�cal form apart from the

ac�ve substance’

• The use of the terminology “Conven�onal vaccine/established

vaccine” for vaccine which the an�gen has been established

• Re-categoriza�on of new adjuvanted vaccine as new vaccine as per

WHO Guideline on Changes to Approved Vaccines

• Change of the requirement for Efficacy parameter for new/novel

vaccine from ‘as required’ to ‘where applicable’ on the basis that

vaccine efficacy data is generally required, unless otherwise

scien�fically jus�fied

ASEAN Varia�on Guidelines (AVG) for Pharmaceu�cal Products:

• Addi�on of a Minor Varia�on No�fica�on (MiV-N) for minor change

in the manufacturing process of an immediate release oral solid

dosage form or oral solu�on

The next ACCSQ-PPWG mee�ng which includes TWG and IWG mee�ngs

will be hosted by Malaysia in April 2019.

On a lighter note, Da Nang is another city in Vietnam siFng as a half point

between Hanoi (northern part) and Ho Chi Minh (southern part) boas�ng

its sandy beaches and French colonial buildings. Da Nang is strategically

located within several UNESCO World Heritage Sites, namely the Imperial

City of Hue, the Old Town of Hoi An and the My Son ruins, making it a

must visit place when planning a trip to Vietnam.

25th ACCSQ-PPWG regulators and industry observers from the Philippines



Editor’s Note: Beyond the usual pharmaceu�cal exper�se, let our own PAPPI colleagues inspire you with their crea�ve wri�ngs and literary pieces..

At first, I thought it was just a simple bump on my neck. No big deal, I just ignored it.

I recently got promoted as a manager in my job in one of the fastest growing companies in Informa�on Services and Technology. It was an

exci�ng experience passionately doing the job that I dreamt of several years back. I have a wonderful boyfriend who just proposed marriage.

For the past 5 years, he was very suppor�ve in fulfilling my life’s goals and plans. I have a caring family whom I look forward to visi�ng every

weekend to spend some �me bonding with them. I have friends whom I can rely on in good and bad �mes of my life. I can never ask for more,

or so I thought…

Days, weeks and months passed by, the bump on my neck started to grow in size. My officemates started no�cing that I am losing weight. Most

of the �me, I felt unusually �red even if I am not exer�ng too much effort doing things at work and at home. Then one �me, I no�ced some

bruises on my arms, back and legs. That’s when I decided to visit a doctor in a nearby hospital.

I pa�ently answered the ques�ons from what they call “complete medical history”. Then, the doctor started examining the different parts of

my body. She paid par�cular aIen�on and interest in the swollen bump on my neck. She asked a lot of ques�ons, when did I started no�cing it,

how was it affec�ng my appe�te, when did it began changing its size, and so on and on.

ADer that, she wrote something on a paper and handed it to me. She told me that it was a referral form to another doctor who specializes in

my condi�on “just to be sure”. So, I went to see this doctor and went through the same process for the second �me. This new doctor told me

to have a blood test and take an�bio�cs for weeks. The bump on my neck did not decrease in size but s�ll grew as weeks passed by. She told

me to undergo a biopsy of the lymph node or the removal of the lump on my neck as what she called it. I also had PET and CT Scans. In the end,

it was confirmed that I have CANCER, Hodgkin Lymphoma Stage II.

At that moment, I was overwhelmed by fear, anxiety and panic. A lot of ques�ons are popping out of my mind, “Why me?”, “What will happen

to me?”, “How long will I live?”, “What will happen to the people I love if I die?”. It is as if everything stopped at that �me. I cannot hear what

the doctor was saying un�l she held my hand and told me that they will do everything for me to make it through this ordeal. And my tears

began pouring out. I started throwing a lot of ques�ons at her and she pa�ently answered each one of them. In the end, she said that we will

need the support of my family, friends, fiancé and all those who love me.

When the treatment started, I learned the importance of a posi�ve aFtude from where I drew my strength and hope. I began relying on God

for healing and believing in the healthcare providers who outstandingly did their job performing the therapies and administering treatment. I

accepted and trusted the medicines that I took and diligently followed

instruc�ons when taking them. I con�nued to lean on my family,

friends, fiancé and all those who love me for support and thanked

them for staying with me during these difficult �mes. I never felt alone,

I was never abandoned. So, I was healed.

It was not an easy and hasty process but I regained my health. The

cancer cells were miraculously removed from my body. The sleepless

and dreading nights of therapies and treatments worked. The

countless medicines restored my well-being. I recovered from this

sickness and I will con�nue to live.

I am Shane, 27 years old. I am a survivor, a cancer survivor.

I am a Survivor, a Cancer Survivor By: Sherlaine Laig, R.Ph.



Editor’s Note: Each genera�on of pharmacists is unique. The circumstances and challenges that each genera�on faces mold the overall for�tude of the pharmacists. In celebra�on of

World Pharmacists Day, we recognize the unheralded work of our regulatory affairs officers in their interac�on with the FDA. We interviewed regulatory pharmacists from the

Genera�on X and Millenials to understand the perspec�ve and dynamics of the regulatory environment during their �me. (Contributors sent their feedback thru email responses.)

QUESTIONS GEN X ( 1965-1979) - Started RA career in 1997 MILLENIALS (1980-2000) - Started RA career in 2016

How do you follow up your

FDA submissions?

We have the opportunity to directly talk to the FDA officer

who handles the review of our product. During this follow-up,

we get to clarify queries that we have on the applica=on.

There is collabora=on between FDA and applicant, e.g. if

there are addi=onal minor requirements requested by FDA,

then both par=es agree on the submission date. Most

importantly, the processing lead =me is faster and more

accurate.

Ini=ally through face-to-face mee=ng w/ FDA officers then

followed by le?ers and phone call

Where do you usually eat? Our choices then were FDA canteen, Fes=val Mall or Alabang

Town Center.

Fes=val Mall

How do you go to FDA? Company car By car (w/ colleague or grab)

What do you look forward

every =me you visit FDA?

We look forward to geAng answers to our technical queries

given that FDA is the agency expert on the regula=ons.

To be able to submit all planned submissions

Who is your “go to” person

and why?

Nobody in par=cular, but anybody who is expert on the

subject ma?er.

Ini=ally Ms. Nida… but now, there is no go to person since

FDA does not have any F2F interac=on anymore.

Who do you think is the best

evaluator/officer and why?

It depends on the topic. Ms. Nida, because she is easy to talk to and she meets half-

way with the client to resolve issues and concerns.

How does FDA look like during

your first few years of visit?

FDA premises were clean and had a good ambiance. FDA

personnel were open to provide service, willing to help,

approachable but some=mes moody.

Crowded

[WORLD PHARMACISTS DAY EDITION]

A FUND RAISING MOVIE SCREENING

06 Oct 2018 (Saturday); 4pm

Greenbelt 1. Cinema 2

Php 500.00 only!

GET YOUR TICKETS NOW!GET YOUR TICKETS NOW!GET YOUR TICKETS NOW!GET YOUR TICKETS NOW!

Text Sol 0917 5281636 or email: [email protected]



PAPPI Birthday Celebrants

Philippine Associa�on of Pharmacists in the Pharmaceu�cal Industry (PAPPI)

Office Address: Philippine Pharmacists Associa�on Bldg. , 815 R. Papa St., Sampaloc, Manila

Tel No.: (02) 736-1816; Website: www.pappi.ph

Email: [email protected]

Secretariat: Charity Box (09178229021)

We are looking for new contributors

for the next edi�ons of PAPPIRUS. If

you are interested, contact the

Publicity and Sports CommiIee by

sending an email to

[email protected]

or [email protected].

EDITORIAL STAFFEDITORIAL STAFFEDITORIAL STAFFEDITORIAL STAFF

Editor-in-Chief Armand James Gaspar

Managing Editors Noemi Natividad-Ibe

Kiven Marasigan

Associate Editors Erlyn Joyce Francisco-Cruz

Irene Gutierrez-Edma

Paul Bernard Ibe

Francis Marod Policarpio

Contributors Armi Grace Gonzales

Sherlaine Laig

“Pharmacists: Your medicines expertsPharmacists: Your medicines expertsPharmacists: Your medicines expertsPharmacists: Your medicines experts” is the theme

of this year’s World Pharmacists Day.

In support of this year’s World Pharmacists Day, we

encourage PAPPI members to share their photos

depicting the relevance of the pharmacy profession

on PAPPI’s official Facebook page with a caption that

should also capture the theme. The Publicity & Sports

Committee will select the top 3 posts based on the

following criteria:

Relevance to the theme: 50%

Originality & Creativity: 25%

Impact (FB No. of Likes): 25%

Please include the following hashtags in your post:

#pappicelebratesworldpharmacistsday #pappi

#worldpharmacistsday

Submission of entries will be from Sep. 21 to Sep 24

noon time.

The top 3 posts will be announced during PAPPI’s 3rd

GMM on 25 Sep 2018 and winners will receive a

special token from PAPPI.

JULY

7 Lousene Rodriguez

7 Winnie Isidro

10 Rowena Dechimo

16 Bubbles Barredo

18 Olivia Quiambao

20 Maria Teresita Carreon

20 Angelique Bulatao

21 Lychee Sevilla

22 Aiza Penalosa

23 Marissa Hugo

25 BabeIe dela Rosa

25 Roceliza Valdez

30 Paola Marie Sabban

AUGUST

1 Meriam Cardones

1 Geraldine Nor Guerina

5 Joyce Britanico

5 Mary Robelle Lontok

6 Patrina de Guzman

7 Arlyn Joy Tibi

8 Altess Gee SoIo

8 Verni Amor Mahimer

11 Tricia Mae Bantog

12 Cherrilie Esquillo

14 Eizel Diane Flores

16 Rachelle Sagcal

18 Lyn Baldric

19 Jakie Vi Azucena

19 Apple Vee Labagnoy

20 Anna Lea Remandas

21 Ihris Jay Terrado

22 Sharrie Madridejos

26 Jona Manalili

28 Charisse Anne For�faes

29 Catherine Fajardo

SEPTEMBER

1 Michelle Carolyn Olaes

4 Joan Naguit

4 Mary Grace Plazuelo

4 Liza Pajarillo

4 Yanna Gatmaitan

4 Kirsten Nicole Batac

7 Dhorina Dinulos

8 Lani Mata

8 Paul Marvin Quizon

9 Sharon Provido

9 Lucienne Avelino

9 Germelina Mercado

10 Ruth Tugano

10 Rhenand Ibisate

11 Anna Navata

16 Alma Aguinaldo

16 Ana Marie Madlangbayan

17 Karl Howald Mar�n

20 Gia de Guzman

21 Marga Mendoza

21 Malou Buisan

26 Juliet Manrique

26 Rheb Camus

27 Kristel Justo

28 Gracielle A�enza

28 Carla Joy David

PH TO CONTEST

Special tokens will be given to

contributors whose ar�cles are

published on PAPPIRUS.


we innovate. we collaborate. we lead. we are pappi. issue4_2018.pdfthe 25 th accsq-ppwg mee˝ng was...

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