FOREIGN GMP REGULATORY INSPECTION and MANAGING CHANGES OF LICENSED FACILITY

DATE:

26 Oct 2016 (Wednesday)

TIME: 9.30am-3 .30pm

VENUE:

Hotel Royale Chulan Damansara

SPEAKERS:

From the National Pharmaceutical Regulatory

Agency (NPRA), Ministry of Health Malaysia.

OBJECTIVES:

1. To disseminate information about the latest regulatory requirements relating to foreign GMP regulatory inspections and management of changes to licensed facility.

1. To provide guidance on how to make a Foreign GMP Inspection application with NPRA.

1. To provide opportunities for the company and NPRA to share issues relating to foreign GMP inspections.

WHO SHOULD ATTEND

Manufacturers, Importers,

Regulatory     Affairs   Managers/Executives,

Product Registration Holder,

TENTATIVE PROGRAM

9.30am|Registration: Morning Coffee & Networking

10.15-10.30am|Welcome Remarks

10.30-11.15am|Foreign GMP Regulatory Inspection

11.15-12.00pm| Managing Changes of Licensed Facility

12.00-12.15pm|Q &A

12.15-2.00pm|Lunch

2.00-2.30pm| Application process for Foreign GMP Inspection

2.30-3.00pm| Evaluation of GMP Evidence

3.00-3.30pm|Q &A

3.30pm|End of session

REGISTRATION FEE

RM550 | ISPE Member

RM800 | Non ISPE Member

RM300 | Government & Academia Member

RM250 | Young Professional Member

USD180 | Foreign ISPE Member

USD250 | Foreign Non ISPE Member

TO REGISTER

Please register via the following link: http://tinyurl.com/ispeforeignGMP

PAYMENT DETAILS

BANK TRANSFER/DEPOSIT

Account name| ISPE Malaysia

Bank| United Overseas Bank (M) Berhad

A/C No.|1623023449

SwiftCode|UOVBMYKLXXX

CHEQUE Payable to| ‘ISPE Malaysia’

Address|6th Floor, Block C, Kelana Business Centre, 97, Jalan SS7/2, 47301 Kelana Jaya, Selangor

FOR FURTHER INFO:

NPRA

Ms. Nadia Mohd Izham nadiaizham@bpfk.gov.my |Tel: +6037801 8435

ISPE

Ms. Rohani Mohammad ask@ispemalaysia.com.my|Tel: +6017338 1788