EPBN-FDA Forum Workshop on E-registration
Date:
Thursday, August 18, 2016
Venue:
Manila B Function Room, Makati Shangri-La
EPBN-FDA Forum Workshop on
E-registration
18 August 2016 | 7:30 AM – 12:00 NN
Manila B Function Room, Makati Shangri-La
The introduction of e-registration for low risk products in the Food and Drug Administration (FDA) has been an important step towards making the registration of products under FDA more efficient and transparent. However, despite notable developments over the past years, the system still has room for improvement. As the FDA turns towards a fully computerized system this year, rolling out e-registration for medium and high risk products, it becomes increasingly important to address current bottlenecks in the system and ensure that it provides an efficient and fast registration process.
Manila B Function Room, Makati Shangri-La
TARIFF
1,800 PhP for EPBN Partner Members
2,500 PhP for non-EPBN Partner Members
The introduction of e-registration for low risk products in the Food and Drug Administration (FDA) has been an important step towards making the registration of products under FDA more efficient and transparent. However, despite notable developments over the past years, the system still has room for improvement. As the FDA turns towards a fully computerized system this year, rolling out e-registration for medium and high risk products, it becomes increasingly important to address current bottlenecks in the system and ensure that it provides an efficient and fast registration process.
In this context, the EPBN Food and Beverages Committee unanimously agreed to hold a workshop on e-registration with the following objectives:
- to ensure clear understanding of the registration process and the specific documentary and other requirements among the private sector;
- to ensure that private sector understands what tools are available to remain updated on new developments in the registration process; and
- to create alignment between FDA assessors and the private sector on the technical specificities and terminologies for different product categories
Agenda:.
| TIME | ACTIVITY |
| 7:30 AM | Registration |
| 8:00 AM | Opening Remarks Henry Schumacher, EPBN Advocacy Manager |
| 8:05 AM | Message from FDA FDA Director of Center for Food Regulation and Research Pilar Marilyn Pagayunan |
| 8:20 AM | Process flowchart of FDA e-registration (simulation) FDA staff |
| 8:40 AM | Reasons for denial FDA staff |
| 9:00 AM | Open forum on FDA e-registration concerns and queries on reasons for denial |
| BREAKOUT SESSION / WORKSHOP PROPER | |
| 9:20 AM | Case studies of frequently misunderstood products and different specifications of product categories by industry & FDA |
| 10:20 AM | Case presentations and open forum |
| 11:05 AM | Synthesis and Action Points |
| 11:25 AM | Awarding of Token of Appreciation to FDA |
| 11:35 AM | Concluding Remarks |
REPLY FORM
Accomplished forms should be sent to Ms. Monica Rivera at monica.rivera@epbn.ph or fax no. 758-6690 or 845-1395.
Accomplished forms should be sent to Ms. Monica Rivera at monica.rivera@epbn.ph or fax no. 758-6690 or 845-1395.
EPBN-FDA Forum Workshop on E-registration
18 August 2016 | 7:30 AM – 12:00 NN | Makati Shangri La, Manila B Function Room
18 August 2016 | 7:30 AM – 12:00 NN | Makati Shangri La, Manila B Function Room
TARIFF:
1,800 PhP for EPBN Partner Members | 2,500 PhP for non-EPBN Partner Members
Name:
Position:
Company:
Address:
Tel:
Fax:
Email:
Position:
Company:
Address:
Tel:
Fax:
Email:
