How to find the right GMP for APIs

Berlin, Germany
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Program Highlights
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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.

More information coming soon.


WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1


Elke von LaufenburgElke von Laufenberg 
Manager Training & Education
Tel: +49 (0) 30 43 655 08-21
Fax: +49 (0) 30 43 655 08-66
Agenda is subject to change.

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.

Estrel Berlin
Sonnenallee 225
12057 Berlin
Tel.: +49 30 6831 0
mail: [email protected]

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.


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

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