Biosimilars Approval to Biogenerics in Clinical Practice

Biological medicines are much more structurally complex and extremely sensitive to manufacturing conditions and therefore more difficult to characterize and produce than small molecule drugs. Even minor changes in manufacturing may lead to significant variations of the cellular systems used for biological production, as well as to differences in the structure, stability, or other quality aspects of the end product, all of which have the potential to affect tolerability and/or efficacy and increase the risk of immune responses. Owing to these issues, specific regulatory guidance on biosimilars is continuously evolving, and there is some disagreement on which studies need to be implemented to approve a biosimilars. According to current literature, the following points on biosimilars deserve consideration: Biosimilars development is characterized by global harmonization, although several not fully answered questions remain regarding extrapolation of indications, switching or interchange ability, and tolerability; in patients with rheumatic diseases, the tolerability and efficacy of biosimilars in clinical practice remain to be established; several medical and patient associations have published position papers on biosimilars requesting that safety, efficacy, and traceability be carefully considered; long-term post marketing studies should be implemented to allow physicians to gain confidence in biosimilars.

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Terms and Conditions

Responsibility

The organizers holds no responsibilities or liabilities of the personal articles of attendees at the venue against any kind of theft, lost, damage, due to any reason whatsoever. Delegates are entirely responsible for the safety of their own belongings.

 

Insurance

No insurance, of any kind, is included along with the registration in any of the events of the organization.

 

Transportation

Please note that transportation and parking is the responsibility of the registrant, Allied Academies will not be liable for any actions howsoever related to transportation and parking.

 

Press/Media

Press permission must be obtained from Allied Academies Conference Organizing Committee prior to the event. The press will not quote speakers or delegates unless they have obtained their approval in writing. The Allied Academies is an objective third-party nonprofit organization and this conference is not associated with any commercial meeting company.

 

Requesting an Invitation Letter

For security purposes, letter of invitation will be sent only to those individuals who had registered for the conference after payment of complete registration fee. Once registration is complete, please contact biosmilars@alliedconferences.org  to request for a personalized letter of invitation, if not received until one month before the scheduled date of event. All the bank charges applicable during refund will be deducted from the account of participant.

 

Cancellation Policy

All cancellations or modifications of registration must be made in writing to finance@alliedacademies.com

If,due to any reason, Allied academies postpone an event on the scheduled date, the participant is eligible for a credit of 100% of the registration fee paid. This credit shall only be used for another event organized by Allied academies within period of one year from the date of rescheduling.

 

Postponement of event

If, due to any reason, Allied academies postpone an event and the participant is unable or unwilling to attend the conference on rescheduled dates, he/she is eligible for a credit of 100% of the registration fee paid. This credit shall only be used for another event organized by Allied academies within period of one year from the date of rescheduling.

 

Transfer of registration

All registrations, after payment of complete registration fee, are transferable to other persons from the same organization, if in case the person is unable to attend the event. Request for transfer of registration must be made by the registered person in writing to contact@alliedacademies.com. Details must include the full name of replaced new registrant, their title, contact phone number and email address. All other registration details will be assigned to the new person unless otherwise specified. Registration can be transferred to one conference to another conference of Allied academies if the person is unable to attend one of conferences.

However, Registration cannot be transferred if intimated within 14 days of respective conference.

The transferred registrations will not be eligible for Refund.

This cancellation policy was last updated on April 04, 2015.

 

 

Visa Information

Keeping in view of increased security measures, we would like to request all the participants to apply for Visa as soon as possible.

Allied academies will not directly contact embassies and consulates on behalf of visa applicants. All delegates or invitees should apply for Business Visa only.

Important note for failed visa applications: Visa issues are not covered under the cancellation policy of Allied academies, including the inability to obtain a visa.

 

Refund Policy:

If the registrant is unable to attend, and is not in a position to transfer his/her participation to another person or event, then the following refund policies apply:

Keeping in view of advance payments towards Venue, Printing, Shipping, Hotels and other overhead charges, following Refund Policy Orders are available:

  • Before 60 days of the conference: Eligible for Full Refund after deduction of $100 towards service Fee.
  • Within 60-30 days of Conference: Eligible for 50% of payment Refund.
  • Within 30 days of Conference: Not eligible for Refund.
  • E-Poster Payments will not be refunded.

Accommodation Cancellation Policy:

Accommodation Service Providers (Hotels) have their own cancellation policies which are applicable when cancellations are made less than 30 days prior to arrival. If in case the registrant wishes to cancel or amend the accommodation, he/ she is expected to inform the organizing authorities on a prior basis. Allied academies will advise the registrant to ensure complete awareness about the cancellation policy of your accommodation provider, prior to cancellation or modification of their booking.

Authorization Policy

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