PDA Industry and Honor Award Winners

Class of 2024

Honorary Membership*

PDA's most prestigious award, conferring lifetime membership benefits to the recipient. The award is given in recognition of very long service, of a very significant nature, to PDA.

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

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  • Honorary Membership
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Frederick Carleton Award*

This award is designated for a past Board member whose services on the Board are determined by his/her peers as worthy of high recognition. It is presented as a tribute to lifetime contributor Fred Carleton.

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

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  • Honorary Membership
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Gordon Personeus Award*

This Award is intended to honor a PDA member for his or her long-term activities and/or volunteer contributions that are of noteworthy or special importance and have positively impacted PDA in several areas over time. It is presented in memory of the late Gordon Personeus, past PDA President and long-time volunteer.

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

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  • Honorary Membership
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Michael Korczynski Award*

This Award is presented to recognize contributions to PDA’s international activities. It is named for Michael S. Korczynski in recognition of the contributions he made toward the development of PDA’s international activities.

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

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  • Honorary Membership
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James P. Agalloco Award

This award is presented annually to the PDA TRI faculty member who exemplifies outstanding performance in education. The selection is based on student and faculty evaluations. It is named for James P. Agalloco in honor of his work in developing the PDA education program.

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

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  • Honorary Membership
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Martin VanTrieste Pharmaceutical Science Award*

This award recognizes a volunteer’s outstanding contributions that have advanced the pharmaceutical sciences. It is presented in honor of past Board Member and long-time contributor Martin VanTrieste.

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

Categories :
  • Honorary Membership
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Edward Smith PDA Packaging Science Award*

This award was created to recognize outstanding contributions to Pharmaceutical Packaging Science. It is presented in honor of Edward Smith and his long-term contributions to pharmaceutical packaging science.

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

Categories :
  • Honorary Membership
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Distinguished Service Award*

Four to six awards are typically given in recognition of volunteers' special acts, contributions, or service over the last year that have contributed to the success and strength of PDA. Examples of the types of activities that are recognized include service as members and leaders of PDA Program Planning committees, Task Forces, Interest Groups, and Chapters.

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

Categories :
  • Honorary Membership
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Frederick Simon Award

This award is presented annually for the best paper published in the PDA Journal of Pharmaceutical Science and Technology (JPST).  It is named in honor of the late Frederick D. Simon, a previous PDA Director of Scientific Affairs.

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

Categories :
  • Honorary Membership
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PDA Letter Article of the Year Award

This reward recognizes an article written by a PDA member during the preceding year that proved popular with PDA’s audience. In addition, the Managing Editor and the Editorial Committee agrees that the article represents quality work deserving of special recognition.

This year's award-winning article is "Understanding Japan Quality"

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

Categories :
  • Honorary Membership
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PDA Asia Pacific Appreciation Award

This award is given in recognition of special volunteer acts contributing to the success and strength of PDA in the Asia Pacific region.

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

Categories :
  • Honorary Membership
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PDA Europe Appreciation Award

This award is given in recognition of special volunteer acts contributing to the success and strength of PDA in Europe.

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

Categories :
  • Honorary Membership
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Outstanding Early Career Professional Award

This award is given in recognition of special volunteer acts contributing to the success and strength of PDA by an Early Career Professional

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

Categories :
  • Honorary Membership
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Service Appreciation Award

This award is given in recognition of activities performed on behalf of PDA and is awarded at the end of service of specific volunteer leadership positions, including:

  • The Board of Directors
  • Advisory Board Chairs (intended to be given after stepping down as immediate past chair but can be given earlier when service is cut short)
  • Interest Group Leaders
  • Chapter Presidents

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

Categories :
  • Honorary Membership
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PDA President’s Award

This Award recognizes a PDA staff member, typically excluding Senior Staff members, whose exemplary performance has contributed to PDA’s success during the previous year.

Stephan K. Roenninger, Dr.-Ing.

Mar 5, 2025, 10:03 AM
Full Name : Stephan K. Roenninger, Dr.-Ing.
LinkedIn Profile Url : https://www.linkedin.com/in/dr-ing-stephan-roenninger-725a9127/
First Name : Stephan
Last Name : Roenninger
Job Title or Position Name : Head External Affairs Europe, International Quality
Company or Organization : Amgen
Stephan works in Quality External Affairs at Amgen on Operations/CMC since 2013. He collaborates cross-functional internally and with external stakeholders by shaping regulatory guidelines, disseminating intelligence, and educate. 

He represents Amgen in Industry associations e.g., leading the EFPIA Manufacturing Quality Expert Group and represents EFPIA on GMP/GDP & inspections and in the ICH-Quality Discussion Group and before on ICHQ9 (Quality Risk Management), ICH Q-Implementation Working Group (ICH Q8-Q11), ICHQ7-Implementation Working Group (GMP for APIs) and ICH Management Committee Subcommittee on training. In the Parenteral Drug Association (PDA) he was at the board, chaired RAQAB and represents as PDA Technical Fellow on Drug Supply and Shortage Management.

Stephan holds a PhD / engineering degree from the Technical University Darmstadt, is appointed as Academic Visiting Expert at Duke-National University of Singapore and was Adjunct Assistant Professor at Georges Washington University. He worked for Roche in a manufacturing site and developed their Global-QMS (1992-2013). He has received numerous awards from regulators incl. FDA, PIC/S, Health Canada and PDA.

Categories :
  • Honorary Membership
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