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How to find the right GMP for APIs

Jun 30, 2016
Berlin, Germany

  • Education
  • Europe
Closed
Program Highlights
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Overview

It was an enormous success that the API manufactures have received their own GMP guideline by ICH because there are significant differences between the GMP requirements for Drug (Medicinal) Products and APIs.

This course will provide practical guidance of key aspects laid down in the ICH Q7 guideline. It will clarify and layout the appropriate GMP standard to be applied by API manufacturers. In particular it will address GMP related topics of quality, production, logistic, engineering and biotechnology.

It is a unique chance to receive first-hand knowledge, interpretation and understanding of ICH Q7 and to ask questions to one of the ICH Q7 authors.

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Agenda

  • Contact

    Elke von LaufenburgElke von Laufenberg 
    Manager Training & Education
    Tel: +49 (0) 30 43 655 08-21
    Fax: +49 (0) 30 43 655 08-66
    Email

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    More information coming soon.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Sonnenallee 225
Berlin, Germany

Estrel Berlin
Sonnenallee 225
12057 Berlin
Tel.: +49 30 6831 0
mail: [email protected]
https://www.estrel.com/en/hotel.html

Hotel Estrel Berlin - Aussenansicht

Estrel Hotel Berlin

Estrel Berlin is Germany’s largest hotel, and we have something to suit every taste and need: 1,125 rooms and suites, five restaurants, three bars, a summer garden with its own landing pier and a modern wellness & fitness area.

The hotel is adjoined to the Estrel Congress & Messe Center, which covers a space of 269,000 sq ft – roughly the size of two football pitches – and houses more than 75 conference rooms providing the ideal conditions for an event of any kind and size.

The stage at the adjacent Estrel Festival Center hosts top quality Las Vegas style entertainment all year round. Our "Stars in Concert" show series and numerous other highly acclaimed in-house show productions give guests from Berlin and around the world "Entertainment at its best".

The Estrel Hotel Berlin’s 1,125 spaciously designed rooms and suites are providing a sanctuary for relaxation as a home away from home with a host of comfort features. Their timeless, contemporary designs provide holidaymakers and experienced travellers alike with the comfort features they expect.

PDA Europe has reserved a limited number of bedrooms until the 26 April 2016. Book your group rate under code word “PDA”.

Single Room Euro 118 per room and night
Double Room Euro 130 per room and night
(excluding breakfast, VAT & Service Charges, excluding 5% City Tax- will apply)

Estrel Berlin

How to get there

The Estrel Berlin’s convenient location and ideal transportation connections mean that we are easy to reach both by car and when using public transport. The nearest slip road to the highway is only 1.5 kilometres away, and we’re only 13 kilometres from Berlin’s Schönefeld Airport (SXF) and from the upcoming Berlin Brandenburg Airport (BER) set to open in the near future. The Sonnenallee S-Bahn commuter train station can be reached on foot in only three minutes, and a bus stop and taxi rank are located right in front of the hotel.

Airports

Berlin Tegel Airport (TXL)
Take the X9 bus line from the airport to the "Jungfernheide" bus stop. Transfer then to the S42 S-Bahn commuter train line (Ringbahn) until you reach the "Sonnenallee" stop.
Public transport journey duration: roughly 40 minutes
Taxi journey duration: roughly 30 minutes
Taxi price: roughly 40 euros

Berlin Schönefeld Airport (SXF)
Take the 171 bus line until you reach the "Sonnenallee" stop.
Public transport journey duration: roughly 40 minutes
Taxi journey duration: roughly 15 minutes
Taxi price: roughly 35 euros

Parking
The hotel has its own underground parking garage offering 450 parking spaces 
Parking Rate - from 8 to 24 hours (daily rate): Euro 18,-

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

4 Ways to register

  • Online Registration
  • FAX: +49 30 436 55 08 66
  • [email protected]
  • Mail: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

695 Euro

All fees given in Euro and excluding VAT (7%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0)30 43 655 08-10
Fax: +49 (0)30 43 655 08-66
Email

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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Contact

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Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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