RDD Asia 2018 will feature a half day of Interactive Workshops on Thursday, November 15, 2018.
Workshops provide an opportunity for companies to sponsor, in a technical rather than an overly-commercial manner, practical and interactive demonstrations of innovative technologies, products, capabilities and services.
Each workshop will last 60 minutes (including demonstration and questions) and should be designed for small groups of 10–40 delegates to encourage audience interaction. Each workshop will be repeated three times to ensure that delegates have the greatest opportunity to attend their preferred selections. Only a limited number of organizations will be selected to host a Workshop.
Workshop Rooms and Equipment
All workshops will be presented in carpeted meeting rooms close to the podium, poster and table exhibit areas at the conference hotel. Locations of each workshop session will be prominently displayed before, and during, the Thursday afternoon session and each room will be clearly signposted.
Room sizes will be matched to the expected attendance, but will not be less than 40 m2.
Workshop rooms are equipped at no charge with:
- A projection screen (1.5 x 2 meters)
- A table (2 meters long x 0.5 meters wide x 0.9 meters high) and chairs for presenters and participants.
- Electrical outlets (230 V – Indian format) are provided. Presenters must supply power adapters.
Please do not hang signs on the walls in your workshop room. No signs may be posted outside your assigned workshop room.
Any equipment or machines you plan to display must fit on the table described above. The maximum authorized weight is 35 kg. If you need additional information about dimensions and weight and if your equipment is likely to raise safety issues at the hotel (for example, if it is noisy or requires in excess of 5 amps or requires compressed gas), please contact the Workshop Coordinator so we can make appropriate arrangements to seek the necessary approvals on your behalf.
- Portable booths and displays are allowed, provided they do not exceed 4 meters width x 2 meters height when set up in the room. They should be delivered to the room dismantled, and parcel dimensions should not exceed 2 meters high x 0.8 meters wide (to get through doors).
- LCD projector rental: Vinsan Events charges approximately INR 8,500 (3.500 Ansi lumen) for an LCD projector if you decide to rent one. Tax is not included (18%). This charge will be invoiced to you by Vinsan Events. Presenters should order AV or other special equipment by e-mailing a completed "Workshop Planning Form" to the Workshop Coordinator before August 15, 2018.
- Other: Don't forget your PowerPoint slides, laptop, LCD projector (if you are bringing your own) or power adaptors. Macbook users should remember to bring adaptors to connect the projector to your computer.
Set-Up and Removal
- The set-up time for your room and equipment is Wednesday, November 14, from 5:00 - 7:00 PM or Thursday, November 15 from 8:30 AM to 12:30 PM.
- Everything should be removed by Thursday, November 15, 2018, 7:00 PM.
- You are responsible for organizing the packing and outgoing shipment of your equipment.
Workshop Briefing Meeting
A briefing meeting will be organized at the Conference hotel before the Workshop Sessions begin. This will be on Wednesday, November 14, at 6.00 PM. The meeting will be chaired by Gerallt Williams.
Responsibilities of Workshop Presenters
- Equipment installation and dismantling, including the provision of tools and packaging supplies.
- The cost for transport, handling and insurance (during transport and at the conference hotel).
- The organization of transport to / from Grand Hyatt Kochi Bolgatty (contacting the carrier, completing forms, labelling boxes, etc.).
- Compliance with all rules and regulations established by the hotel.
- Clean-up fees if the hotel determines that excessive cleaning is needed.
- Items and valuables left in the workshop rooms. However, the hotel will lock Workshop rooms on request.
The Small Print: Neither RDD Online, Aptar Pharma, nor Vinsan Graphics assumes any responsibility for property loss, damage, personal injury or other claims related to the Workshop space.
Workshop Descriptions and Selection
During online registration, registrants are able to select up to three Workshops. Workshops are repeated three times to ensure that registrants have the greatest opportunity to attend their preferred selections.
Assessing Bioequivalence for Nasal Sprays and Dry Powder Inhalers: Application of Physicochemical Test Methods
Two techniques which are referenced by the FDA in their bioequivalence guidance documents will be covered using case studies: Morphologically Directed Raman Spectroscopy (MDRS), used to obtain component-specific particle size and size distribution measurements for APIs present within OINDP formulations; and Laser Diffraction droplet sizing. Attendees will leave with a better understanding of how component-specific particle size data obtained using MDRS can then help with formulation elucidation, dispersion of the API both before and after device actuation, and how these parameters are related to demonstrating bioequivalence.
Cooperation in the Qualification and Validation of Primary Packaging for Dry Powder Inhalers to Gain Generic Drug Registration
The goal of this workshop is to show the main differences in regulatory filing approaches (with a focus on generics) in different countries. Participants will look at key areas of aluminum primary packaging, including: material processing, prototyping & development, troubleshooting, extractables and leachables, quality systems and DMFs (drug master files) or other regulatory dossiers and how all these factors are key to successful regulatory approvals worldwide.
Decoding FDA’s Recent Combination Drug Product Guidance: Applications to DPIs, pMDIs, and Nasal Sprays
This presentation will provide guidance concerning future submissions of combination products. It will review various topics, including: the definitions of combination products, NDA/ANDA submissions, regulatory pathway review, Human Factor studies in the context of combination product, sponsor/device supplier/regulators expectations. Finally, it will review EMA’s strategy as they elevate their requirements. Attendees will gain practical insights to navigateFDA/EMA expectations for device information inNDA and ANDA submissions for combination products in this changing and challenging regulatory landscape.
Unit-dose Dry Powder Inhalers: Challenges and Opportunities to Meet Patient Needs
This workshop will focus on various aspects of Human Factors, including handling of powder formulations, device development, and targeting high fine particle fractions and drug delivery using cost effective DPI solutions. New opportunities with regard to materials, airflow designs and ergonomic features for patient handling will also be reviewed. The workshop aims to provide attendees with an overview of unit-dose DPI development pathways and how to successfully overcome the challenges involved in bringing these inhaler devices to the market.
Get the Right Grade: An Inhaled Lactose Guide for Dry Powder Inhaler (DPI) Formulations
Using case studies, this workshop will explain how the particle size of the carrier significantly changes the delivered dose and fine particle fraction of DPIs. It will provide insight into the interplay between carrier lactose with the type of device to reveal what type of carrier is most suitable for which type of device. The case studies will also explore how lactose fines are often used in conjunction with carrier lactose (ternary powder formulations) to optimize DPI performance. By attending this session participants will gain a deeper understanding of what lactose carrier and fines can achieve in a DPI formulation.
A Step-wise Guide to Orally Inhaled and Nasal Drug Product (OINDP) Development
This workshop will describe the development process of an OINDP candidate from designing early stage device/formulation screening to performing the range of in vitrocharacterization tests and submission to relevant regulatory authorities. Attendees will come up with real problems they might encounter during OINDP development and the instructors will provide feedback and discuss solutions. Troubleshooting approaches for common roadblocks encountered during development will also be covered. Participants will gain an understanding of a scientific and cost/time effective approach towards OINDPs from early development to regulatory submission.
Please ensure anyone shipping packages to the meeting on your behalf receives a copy of these instructions.
Hotel Shipping & Receiving Contact Information:
Name: Ronnie Noble
Mobile Phone: +91 7593880438
Packages for the Grand Hyatt Kochi Bolgatty should be timed to arrive between October 29 and November 9, 2018, delivered between the hours of 8:00 am and 3:00 pm, Monday to Friday. Packages will be brought to your exhibit table or poster.
Labeling Your Shipment
Please use the Hotel Delivery Label for your shipment in addition to your Main Shipping Label.
Grand Hyatt Kochi Bolgatty
RDD Asia 2018 Conference
Hotel Phone: +91 484 275 1008
- Main Shipping Label should include the Ship-to Address above as well as your company’s return address or that of your shipping company.
- Fill out the Hotel Delivery Label completely and attach to outside of box(es). Include your name, your company name and the purpose of the box contents (e.g., Poster, Exhibit Table, Workshop).
- Number each box and the total number of boxes in your shipment (e.g., Box 1 of 3, Box 2 of 3, Box 3 of 3).
Contact your shipper for specific instructions. The following is a guide based on past experience. Neither RDD Asia 2018 nor the hotel accepts responsibility for items delayed, lost or damaged in transit to or from Grand Hyatt Kochi.
- Please ensure additional time for customs clearance in India. All shipments are subject to inspection.
- Transport and custom charges are the responsibility of the sender. Grand Hyatt will not pay transport or customs bills when carriers deliver your shipment. Please ensure that transport and customs fees are duly prepaid to avoid any delivery issues.
- Exhibit boxes should be no bigger than 1.0 meter wide, 1.2 meters high and 1.2 meters deep.
- Package fragile equipment carefully. Dangerous or suspicious looking materials should not be sent through the mail or via carrier services.
- Label boxes clearly as follows:
- RDD Asia 2018 – Exhibition (Box No. 1/3, 2/3…)
- RDD Asia 2018 – Poster (Box No. 1/3, 2/3…)
- RDD Asia 2018 – Workshop (Box No. 1/3, 2/3…)
- RDD Asia 2018 – Delegate Bags (Box No. 1/3, 2/3…)
- Please ensure that the return address is clearly displayed.
- Grand Hyatt may charge handling fees in the case of heavy or bulky parcels; such fees are the responsibility of the shipper.
- At the same time you send your package(s), e-mail Mr. Ronnie Noble (firstname.lastname@example.org), Senior Sales Manager, Grand Hyatt Kochi, to let him know to expect your shipment (include expected arrival, weight and number of packages sent).
- You are responsible for organizing the packing and outgoing shipment of your materials. Please contact your carrier (DHL, Fedex, UPS, etc.) and complete the appropriate forms and labels.
- Remember to pack a roll of tape and shipping forms for return shipping after the conference.
- Parcels must be picked up from this address no later than November 23, 2018.
Please contact Prachi Wadiwala-Singhai, Workshop Coordinator.