International Symposium on Drug Product Quality,

Equivalency and Regulations

Century Park Hotel, Manila, Philippines

6 -7 November 2012

Target participants

Pharmacists from the community, hospitals and industries (both drug and non-drug companies), regulatory and government agencies (ie. FDA and DOH)

Pharmacy educators all over the country (PACOP and non-PACOP members)

Clinicians Medical Representatives

Members of Hospital Pharmacy and Therapeutics Committee

Clinical Research Associates Analysts of pharmaceutical testing

laboratories

Objectives

At the end of the symposium, the participants must be able to:

1. Understand the current challenges and future directions on drug product quality and equivalency in various practice settings

2. Compare local and international standards and regulations on generic medicines

3. Discuss the in vivo and in vitro methods in assuring the quality and equivalency of Generic medicines

4. Discuss the recent trends in dissolution testing and method development

5. Understand the components of compendial process and validation of compendial methods

Program Chairs:

Dr. Imelda G. Peña Dean, UP College of Pharmacy

Dr. Vinod P. Shah AAPS/ FIP

Sponsored by the International Pharmaceutical Federation (FIP), American Association of Pharmaceutical Scientists (AAPS), University of the Philippines – College of Pharmacy (UPCP) and the Philippine Association of

Colleges of Pharmacy (PACOP)

Day 1: 6 November 2012, Tuesday Morning Session

8:00 - 8:30 Registration

8:30 – 9:00

Opening Ceremonies

Invocation and National Anthem

Welcome Remarks Dr. Imelda G. Peña Dean, UP College of Pharmacy President, PACOP

Opening Remarks Dr. Vinod P. Shah AAPS/FIP

Overview of the Program Ms. Jean Flor Camu-Casauay Chair, CPE Committee, UP College of Pharmacy

Plenary Session This session will provide deeper insights on the present situation, challenges and future directions in

the quality assurance of dug products in general and of generic medicines in particular. This will also present local and international regulatory guidelines on generic medicines.

9:00 – 9:30 Regulatory Challenges in Assuring the Quality and Equivalency of Generic Medi-cines

Speaker to be confirmed Philippine FDA

9:30 – 10:00 Why Generic Equivalence: Historical, Cur-rent Perspectives and Impact on the World Health

Dr. Leslie Z. Benet University of California San Francisco

10:00 – 10:30 Break

10:30 – 11:00 USFDA Regulations for Generic Products Dr. Vinod P. Shah AAPS/ FIP

11:00 – 11:30 Balance Between Quality and Cost of Medicines in the Philippines

Mr. Tomas Marcelo G. Agana III President, Philippine Chamber of the Pharmaceutical Industry (PCPI)

11:30 – 12:00 Enhancing Pharmacy Curricular Pro-grams : From Theory to Practice

Dr. Imelda G. Peña Dean, UP College of Pharmacy President, PACOP

12:00 – 12:30 Open Forum

12:30 – 2:00 Lunch Break

Day 1: 6 November 2012, Tuesday Afternoon Session

Plenary Session This session will explain the rationale of generic equivalence with emphasis on in vivo testing meth-

ods. This will also review the approval process of generic medicines in the US setting.

2:00 – 2:30 Generic Drug Approval Process: Require-ments for ANDA Submissions by US FDA

Dr. Nhan L. Tran Senior Associate, Lachman Consultants

2:30 – 3:00 Bioanalytical Analysis and Data Submis-sion Requirements in Bioequivalence Submission

Dr. Vinod P. Shah AAPS/ FIP

3:00 – 3:30 Break

3:30 – 4:00 Recent FDA Inspection Trends for Bioanalytical Laboratories

Dr. Nhan L. Tran Senior Associate, Lachman Consultants

4:00 – 4:30 Open Forum

Day 2: 7 November 2012, Wednesday Morning Session

Plenary Session This session will emphasize the importance of building quality into a drug product more than testing. This will also highlight BCS-based biowavers as an alternative approach in demonstrating equivalence

and drug product interchangeability.

9:00 – 9:30 Quality Beyond the Laboratory Ms. Frances Evelyn P. Robles Executive Director, Philippine Chamber of the Pharmaceutical Industry (PCPI)

9:30 – 10:00 The Biopharmaceutics Classification System (BCS) and Biowaivers

Dr. Vinod P. Shah AAPS/FIP

10:00 – 10:30 Break

10:30 – 11:00

The Biopharmaceutics Classification System (BCS) and the Biopharma-ceutics Drug Disposition Classifica-tion System (BDDCS)

Prof. Leslie Z. Benet University of California San Francisco

11:00 -11:30 Rationale Approach for In Vitro/ In Vivo Correlation

Dr. William Torres President, University of Sto. Tomas Center for Drug Research, Evaluation and Studies (UST CeDRES)

11:30 - 12:00 Open Forum

12:30 – 1:30 Lunch Break

Day 2: 7 November 2012, Wednesday Afternoon Session

Plenary Session The last session will include dissolution methods and specifications with emphasis on the evolving role of dissolution testing as a predictor of in vivo drug product performance. In addition, compo-

nents of the compendial process and validation of compendial methods will also be discussed.

1:30 – 2:00 Development of Dissolution Test Methods

Dr. Vinod P. Shah AAPS/FIP

2:00 – 2:30 Compendial Process Dr. Leonel Santos Senior Scientific Liaison, USP

2:30 – 3:00 Break

3:00 – 3:30 Importance of Dissolution Test Dr. Nhan L. Tran Senior Associate, Lachman Consultants

3:30 – 4:00 Validation of Compendial Methods Dr. Leonel Santos Senior Scientific Liaison, USP

4:00 – 4:30 Open Form

4:30 – 5:00

Closing Ceremonies

Awarding of Plaques, Certificates & Tokens

Dr. Imelda G. Peña Dean, UP College of Pharmacy President, PACOP Dr. Vinod P. Shah AAPS/FIP

Concluding Remarks Dr. Leonel Santos Senior Scientific Liaison,USP

Participant Category Early Bird* Regular International

Undergraduate Student 3500 Php 4000 Php 150 USD

Government Employee 4500 Php 5500 Php 200USD

Academe (PACOP Member) 4500 Php 5500 Php -

Academe (Non-PACOP Member) 5000 Php 6000 Php 200 USD

Private Professionals/ Practitioners 6000 Php 7000 Php 225 USD

3 Step Registration Process

Registration is as EASY as 1-2-3!

Step 1 Fill-up the attached registration form Step 2 Deposit payment thru Security Bank Account Name: Philippine Association of Colleges of Pharmacy Account Number: 0341024961001 Step 3 E-mail or Fax the Registration form and Deposit Slip Fax: (02) 526-6118 Email: cpe.upcp@gmail.com

What to do next?

Wait for the registration confirmation letter via Email from our team within 3 working days.

Participants will only be officially registered upon receiving the confirmation letter.

Present the print-out of the confirmation letter on the first day of the CPE to claim your kit.

If you wish to pay on-site, but would like to notify us of your attendance, please send us the registration form via Fax or E-mail and wait for a reply from our team. Remember to bring your copy on the day of the CPE for on-site payment.

NOTE: Due to the LIMITED NUMBER OF SLOTS for this CPE event, only the participants who have completed the entire registration process will be prioritized.

Registration Fees

*Early Bird Registration must be accomplished on or before September 15, 2012 *Registration fee includes ID, CPE Kit, Lunch and Snacks

For direct inquiries please contact: Phone: (+632) 525-4434 Email: cpe.upcp@gmail.com

This CPE includes lectures by local and international experts on:

Challenges in assuring quality of generic medicines in various practice settings

Local and International regulatory guidelines on generic medicines

Recent approaches and test methods in ensuring generic equivalence

Components of the USP compendial process and validation of compendial methods